The Effect of Upper Extremity Strengthening on Functionality, Muscle Strength and Trunk in Children With Cerebral Palsy

October 9, 2023 updated by: Hatice Adiguzel, Kahramanmaras Sutcu Imam University

The Effect of Different Upper Extremity Strengthening Trainings on Functionality, Muscle Strength and Trunk in Children With Cerebral Palsy in Kahramanmaras

Cerebral Palsy (CP) is an activity limitation, movement and posture deficiencies in early stage of life. In 80% of these children, upper extremity (UE) dysfunctions are observed, which leads to loss of quality of life, resulting in limited participation in activities of daily living (ADL). When the hands are affected in UE, fine motor skills such as grasping, writing and object manipulation are usually limited. This results in inadequate use of the extremities in functional activities. Although all children with CP are known to be affected by UE, studies in terms of physiotherapy and rehabilitation methods mostly focused on children with hemiparetic CP. Similar problems are observed in children with bilateral involvement. However, a wide variation is observed in the bimanual performance of children with hemiparetic and bilateral involvement. Studies evaluating UE activities in children with CP; emphasized that the inability to manipulate objects manually is one of the most important reasons for the restriction of participation in ADLs. Physiotherapy and rehabilitation programs include many neurodevelopmental treatment approaches including stretching, strengthening, positioning, splinting, casting, orthosis selection and movement facilitation. However, it is known that studies investigating the current efficacy of these treatments on UE functions mostly focus on unilateral CP. Interventions that focus on improving UE functions in children with bilateral CP are limited. In UE rehabilitation in bilateral CP; states that target-focused therapy, bimanual intensive task specific training programs and trainings such as HABIT (intensive bimanual training of the upper extremity) involving the lower extremity have been used, but there is only evidence for HABIT-ILE (HABIT involving the lower extremity). In the literature, it is observed that strengthening training with the Proprioceptive Neuromuscular Facilitation (PNF) method, which makes a significant contribution to muscle strength balance, is mostly used in lower extremity rehabilitation in these children. In this study, in the UE rehabilitation of children with hemiparetic and diparetic CP; in order to stimulate motor responses and improve neuromuscular control and function, the superiority of the PNF approach applied with scapular and UE patterns over the traditional Neurodevelopmental Therapy (NGT-Bobath) method will be determined.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

European SP Surveillance (SCPE), CP subtypes according to the dominant type of tone and movement abnormality; divided into spastic, dyskinetic and ataxic CP. Spastic type SP; unilateral spastic (hemiparetic) and bilateral (quadriparetic and diparetic), dyskinetic SP; defined as dystonic and choreoathetotic. Spastic type constitutes 90% of this population and bilateral/unilateral involvement is observed in this group. In 80% of these children, upper extremity (UE) dysfunctions are observed, which leads to loss of quality of life, resulting in limited participation in activities of daily living (ADL).Children with CP as a result of damage to the motor cortex and corticospinal tracts; develop abnormal movement patterns by having difficulties in reaching, grasping and fine motor skills of UE. When the hands are affected in UE, fine motor skills such as grasping, writing and object manipulation are usually limited. This results in inadequate use of the extremities in functional activities. Although all children with CP are known to be affected by UE, studies in terms of physiotherapy and rehabilitation methods mostly focused on children with hemiparetic CP. The most common in children with hemiparetic CP; increase in muscle tone and decreased normal joint movement (ROM), decrease in UE muscle and grip strength, primitive grasping reflex, loss of speed and dexterity are observed. In addition to pure motor impairment, sensorimotor problems are also observed. Similar problems are observed in children with bilateral involvement. However, a wide variation is observed in the bimanual performance of children with hemiparetic and bilateral involvement. Studies evaluating UE activities in children with CP; emphasized that the inability to manipulate objects manually is one of the most important reasons for the restriction of participation in ADLs. In a study examining UE disorders, hand dexterity, grip strength and functionality in ADLs in children with diparetic CP; it was emphasized that these children also had deficiencies in dexterity, grip strength and functions in ADL. Therefore, it has been shown that these children are also negatively affected in terms of hand skills, coordination, UE muscle strength, grip strength, ADL and functional skills compared to their healthy peers. Observing that UE rehabilitation in CP remains in the background, studies on the pathophysiology and treatment of UE sequelae in the last 5 years have come to the fore. Physiotherapy and rehabilitation programs; it includes many neurodevelopmental treatment approaches including stretching, strengthening, positioning, splinting, casting, orthosis selection and movement facilitation. However, it is known that studies investigating the current efficacy of these treatments on UE functions mostly focus on unilateral CP. Interventions that focus on improving UE functions in children with bilateral CP are limited. In UE rehabilitation in bilateral CP; states that target-focused therapy, bimanual intensive task specific training programs and trainings such as HABIT (intensive bimanual training of the upper extremity) involving the lower extremity have been used, but there is only evidence for HABIT-ILE (HABIT involving the lower extremity). In the literature, it is observed that strengthening training with the Proprioceptive Neuromuscular Facilitation (PNF) method, which makes a significant contribution to muscle strength balance, is mostly used in lower extremity rehabilitation in CP. In this study, in the UE rehabilitation of children with hemiparetic and diparetic CP; in order to stimulate motor responses and improve neuromuscular control and function, the superiority of the PNF approach applied with scapular and UE patterns over the traditional Neurodevelopmental Therapy (NGT-Bobath) method will be determined. As a result of this study, it is thought that in addition to traditional NGT-Bobath treatment approaches, muscle strengthening with scapular pattern and upper extremity patterns of PNF can be an effective treatment alternative in the UE rehabilitation of children with CP, and it is thought that UE functional skills, muscle strength and trunk control of individuals will be positively affected. Included children will be randomized by simple randomisation and divided into 2 groups. An exercise approach with PNF UE patterns will be applied to the first group for 30 minutes, 3 days a week for 6 weeks. UE rehabilitation consisting of Neurodevelopmental Treatment (NGT-Bobath) approaches will be applied to the second group for 6 weeks, 3 days a week, 45 minutes a day. Treatments will be carried out by the same doctor physiotherapist investigator. Evaluations will be made twice, before and after the treatment. All assessments will be made by a blind doctor physiotherapist investigator who is unfamiliar with the treatment groups. Alongside the studies in the literature, this study will be the first to compare the effectiveness of the use of UE patterns of PNF in children with hemiparetic and diparetic CP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kahramanmaras, Turkey, 46100
        • Kahramanmaras Sutcu Imam University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Having been diagnosed with CP according to SCPE criteria
  2. Be between 8-18 years old
  3. Volunteering to participate in the study
  4. Hand functions 1-2 according to MACS
  5. To be at the level of 1-2-3 according to the GMFCS (Gross Motor Function Classification System)
  6. Individuals with hemiparetic-diparetic CP who can take verbal commands
  7. Upper extremity muscle tone ≤ 2 according to Modified Ashworth Scale (MASH)

Exclusion Criteria:

  1. Less than 8 years old, over 18 years old
  2. Receiving any UE surgery / Botulinum toxin (Btx) treatment in the last 6 months
  3. Having other known neurological disease
  4. Any upper extremity contracture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: PNF/Interventional
Upper extremity and scapular patern of PNF exercise approach will be applied to the first group for 6 weeks, 3 days a week, 30 minutes a day.
Other: muscle strengthening exercise/Proprioceptive Neuromuscular Facilitation (PNF)
Muscle strengthening with scapular and upper extremity patterns of PNF exercise approach will be applied to the first group for 6 weeks, 3 days a week, 30 minutes a day.
Other Names:
  • Proprioceptive Neuromuscular Facilitation (PNF)
Experimental: NDT/Experimental
Upper extremity strengthening exercises consisting of Neurodevelopmental Therapy (NGT-Bobath) approaches will be applied to the second group for 45 minutes, 3 days a week for 6 weeks.
Other: traditional physiotherapy approach
Traditional upper extremity strengthening and tonus regulation (weight shifting, weight bearing, active reaching in sitting exercises) exercises consisting of Neurodevelopmental Therapy (NDT-Bobath) approaches will be applied to the second group for 45 minutes, 3 days a week for 6 weeks.
Other Names:
  • Neurodevelopmental Therapy (NDT-Bobath)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The change of Manual Ability Classification System (MACS)
Time Frame: first day of intervention and after the 6 weeks
Manual Ability Classification System will be used in hand skills for the evaluation of upper extremity. MACS is a system that classifies children's ability to handle objects during their daily activities. While MACS evaluates the participation of both hands in activities together, it does not evaluate the hands separately.
first day of intervention and after the 6 weeks
The change of the Abilhand Kids Scale
Time Frame: first day of intervention and after the 6 weeks
The Abilhand Kids scale is the Abilhands Kids questionnaire, a parent questionnaire that describes the child's ease or difficulty in performing bilateral activities for the assessment of upper extremity skills. 21 items; relates to activities of daily living, such as taking off a T-shirt, filling a glass of water, or putting on a backpack. Scoring items; recorded as impossible, difficult, or easy. After the survey is completed, it is scored regardless of how the items are completed. A maximum total of 42 points is obtained. Scores are '0 = Impossible', '1 = Difficult' and '2 = Easy'. A maximum of 42 points can be obtained. Higher score indicates better score.
first day of intervention and after the 6 weeks
The change of the Jebsen-Taylor Hand Function Test (JEFT)
Time Frame: first day of intervention and after the 6 weeks
The Jebsen-Taylor Hand Function Test (JEFT) consists of a series of subtests representing hand functions in daily life for the evaluation of hand functions. Separate tests are performed for the dominant and non-dominant extremities, and the time to perform five tests for each hand is recorded in seconds. Apart from the sub-parameter of writing, a total of 6 functions, including turning the page, throwing small objects into the box, warning to eat, lining up the checkerboards, lifting large-light objects and lifting large-heavy objects, are standardized and implemented.
first day of intervention and after the 6 weeks
The change of the 9-hole Peg test (9DPT)
Time Frame: first day of intervention and after the 6 weeks
The 9-hole Peg test (9DPT) is one of the most commonly used tools to assess dexterity. It is an upper extremity skill test that can be completed in a short time. Tests can be done on both hands. Test materials consist of nine holes on a flat, small test battery and nine wooden sticks that fit into them. The subjects are asked to take the rods one by one from the chamber at the top of the test battery and place them in the holes at the bottom of the chamber without any order, then take the rods out of the holes and put them in the upper chamber. Time taken to complete the test, sec. recorded in . The test is reliable and valid.
first day of intervention and after the 6 weeks
The change of the Purdue-Peg board test
Time Frame: first day of intervention and after the 6 weeks
The Purdue-Peg board test (PPBT) is one of the most commonly used tests for selecting personnel for jobs that require motor skills and coordination. It is a test that also measures fingertip dexterity required in assembly works. Washers, rings and small nails are used in this test. The test completion time is recorded in seconds. The test is valid and reliable.
first day of intervention and after the 6 weeks
The change of the strength of upper extremity muscle
Time Frame: first day of intervention and after the 6 weeks
Strength of bilateral pectorals, rhomboids, serratus anterior, trapezius, deltoid, supraspinatus, infraspinatus, teres minor, biceps brachy, wrist extensors and flexors with digital muscle strength measurement device ((Commander Echo Base Kit+Echo Muscle Tester (J-Tech)).
first day of intervention and after the 6 weeks
The change of the Trunk Control Measurement Scale (TCMS)
Time Frame: first day of intervention and after the 6 weeks
The Trunk Control Measurement Scale (TCMS) consists of two main parts: static sitting balance and dynamic sitting balance. Static sitting balance examines static trunk control during movements of the upper and lower extremities. Dynamic control of sitting; It is divided into two as selective motor control and dynamic reach. Selective control of dynamic sitting balance is a scale that evaluates certain movements of the trunk in three planes (flexion, extension, lateral flexion and rotation). Total score ranges between 0 and 58 and higher scores reflect better control.
first day of intervention and after the 6 weeks
Hand grip strength
Time Frame: first day of intervention and after the 6 weeks
Hand grip strength will be measured with Jamar hand dynamometer.
first day of intervention and after the 6 weeks
Pinch grip strength
Time Frame: first day of intervention and after the 6 weeks
Pinch grasp strength will be measured by Pinch Meter.
first day of intervention and after the 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The change of the Modified Ashworth Scale (MASH)
Time Frame: first day of intervention and after the 6 weeks
The Modified Ashworth Scale (MASH) is a method used to determine the severity of spasticity. It is based on the subjective rating of the resistance felt during the examination. Spasticity of the bilateral pectoralis, elbow flexors, pronators, wrist and finger flexors muscles in the upper extremity will be evaluated. The tone felt in these muscles against passive movement is classified as follows; 0: No increase in tone, 1: Slight increase in tone characterized by catching and relaxation or mild resistance at the end of the ROM, 1+: Slight increase in tone characterized by minimal resistance in the remaining ROM (less than half) after capture, 2: Significant tone over most of the ROM increase, but the affected joint can be moved easily, 3: Significant increase in muscle tone, passive movement is difficult, 4: The involved part is rigid in flexion or extension.
first day of intervention and after the 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kahramanmaras Sutcu Imam University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: zekiye ipek katirci kirmaci, PhD, Kahramanmaras Sutcu Imam University
  • Study Chair: mehmet göğremiş, PhD, Kahramanmaras Sutcu Imam University
  • Study Chair: Deniz Tuncel Berktaş, Proffessor, Kahramanmaras Sutcu Imam University
  • Study Chair: Cengiz Dilber, Proffessor, Kahramanmaras Sutcu Imam University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • hatice

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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