The Effect of Upper Limb Loading During Partial Body Weight Support Treadmill Training in Children With Cerebral Palsy

June 30, 2022 updated by: Alya Abdelghafour Alkhajeh

The Effect of Upper Limb Loading With External Weights During Partial Body Weight Support Treadmill Training on Gait and Trunk Control in Ambulatory Children With Cerebral Palsy: A Randomized Controlled Trial

Objectives:

To look for the effect of upper limb loading with external weights during partial body weight support treadmill training on gait speed, gait endurance and trunk control.

Hypothesis:

Investigator's hypothesis is that loading the upper limb with 1 lb. external weights during partial body weight support treadmill training is more effective than partial body weight support treadmill training without loading of the upper limbs in improving gait speed, gait endurance and trunk control.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder which affects the child's motor and sensory system, and consequently posture and walking. The underlying etiology is considered multifactorial, and no specific etiological factor has been blamed. While it may be seen in the prenatal, neonatal, and postnatal period, prenatal factors account for 70 to 80 % of all cases. Although the incidence of cerebral palsy widely varies worldwide, it has been often estimated as 1.5 to 2.5/1000. While the prevalence in young people is as high as 74%. One of the characteristics of CP is gait abnormalities because of myasthenia, spasticity and impairment of movement. Children with CP have difficulties in activities, which severely affect the children's quality of life. There is no cure for CP. WHO considers limb movement function as the main rehabilitation goal. Walking capacity training of CP needs to be taken seriously. Physiotherapy is considered the core part of CP children rehabilitation due to the risk of neurosurgery and side effects of drug intervention.

Many of the gait deviations observed in neurologically impaired patient results from their inability to adequately bear weight through their affected lower extremities during the loading phase of the gait cycle. Treadmill walking with partial body weight support (PBWS) using a harness seems to address the problem. It allows even a patient with severe weakness of lower limb extensor muscles to go through the gait cycle because lower levels of muscle forces are needed to support the body mass compared with over ground walking. In addition, the harness provides a sense of secure to the patient who has fear of falling.

Partial body weight support (PBWS) systems have been widely used as an alternative therapeutic strategy for gait training in different populations, including individuals with stroke , Parkinson's disease , Spinal cord injury and children with cerebral palsy.

Some individual studies suggested that treadmill training with body weight support was superior to treadmill training alone. The addition of body weight support makes repetitive training far more feasible for a boarder range of clients and allows for more flexibility in terms of optimizing speed and training kinematic patterns for those with weakness of other impairments limiting their gait function by increasing safety and decreasing the physical work necessary by one of more therapists. Many studies showed the effectiveness of body weight support training on gait and gross motor function in the rehabilitation of CP.

The trunk plays a critical role in the organization of postural reaction. The primary contribution of the trunk muscles is to stabilize the spine and trunk, and this stabilization is essential for free and selective movements of the head and the extremities. Children with CP frequently show impaired trunk control, which can affect performance of activities of daily life such as sitting, reaching and walking. The trunk was described as a key segment in the organization of postural stabilization and orientation control.

Upper body movement during walking provide information about balance control and gait stability, and children with CP exhibit a general increase of upper body acceleration compared to typically developing (TD) children which present a progressive decrease of acceleration from pelvis to head. Also, it has been found that excessive arm swing significantly increases local dynamics stability of human gait. And children with CP appear to rely on 'guard' arm posture as a compensation strategy to maintain balance while walking compared to newly walking toddlers. Spasticity and associated movements are also important contributing factors. The hand position of children with unilateral CP has been found to be more elevated and anterior, and their upper arm was rotated more posterior than typically developing children. A study showed that facilitation of arm swing in specific situations possibly enhances safety and reduces the risk of falling in children with CP. Using arm cycling exercise has been found as an effective method for improving both arm swing and leg angular displacements during gait of children with hemiplegic CP. Also, it has been found that bilateral upper extremity exercises has a positive effect on trunk performance and alignment in stroke patients. From all of this physiotherapists get to know the importance of involving the upper limbs in the rehabilitation program for children with CP to improve gait.

A study indicated that walking while moving hand weights through large range of motion provides a combined upper and lower body aerobic stimulus that is sufficient for endurance training for persons with poor to excellent levels of aerobic fitness. Other studies looked for the physiological effect of hand-held weights during walking in normal adults. However, according to our knowledge no studies looked for the effect of upper limb external weights on gait and trunk in children with cerebral palsy. The investigators expect that placing an external weight around the both wrists while walking on the treadmill with partial body weight support will improve trunk control and gait in ambulatory children with cerebral palsy. The purpose of this study is to investigate if adding upper limb external weights during gait training using PBWS can increase the walking endurance, speed and trunk control in ambulatory children with CP.

Objectives:

To look for the effect of upper limb loading with external weights during partial body weight support treadmill training on gait speed, gait endurance and trunk control.

Hypothesis:

Investigator's hypothesis is that loading the upper limb with 1 lb. external weights during partial body weight support treadmill training is more effective than partial body weight support treadmill training without loading of the upper limbs in improving gait speed, gait endurance and trunk control.

Trial Design:

Randomized control trial

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • 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

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

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of CP confirmed by the neurologist
  • Age between 4 to 8 years
  • Both genders
  • The level of gross motor function is between level I and II according to Gross Motor Function Classification System (GMFCS)
  • The degree of spasticity according to Modified Ashworth Scale range between grade 1 and grade 2
  • Children should be cognitively competent with IQ level not less than 60% and able to understand and follow instructions, as well as, in general they are cooperative
  • Only Arabic and English speakers will be recruited in the study

Exclusion Criteria:

  • Had any orthopedic surgery or spasticity altering procedure in the previous 12 months
  • Children with visual, auditory, vestibular or perceptual deficits.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Upper Limb Loading Group
Partial body weight support treadmill training with upper limb external weights in addition to conventional treatment: balance, gait training, facilitation for normal development
Other: Upper limb loading
1 lb. external weight will be wrapped around both wrists during partial body weight support treadmill training. The partial body weight support treadmill training will be given for a maximum of 30 minutes and will finish earlier if the child asked to stop, or if the child stopped stepping. Body weight support will be systematically reduced, walking speed will be progressively increased over the training period, upright standing posture will be emphasized and normal kinematic components of the gait cycle will be facilitated during the training session. The training protocol for the current study will consist of 2 training sessions per weeks with at least one day in between and will last for 6 weeks.
No Intervention: Control Group
Partial body weight support treadmill training without upper limb external weights in addition to conventional treatment: balance, gait training, facilitation for normal development

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline 10-meters walk test at 6 weeks
Time Frame: At the baseline (before treatment starts) and 6 weeks (at the end of the treatment)
It it a measure of walking performance because it has been shown to 1- provide a useful measure of walking endurance, 2- be a representative measure of a child's community walking speed, and 3- have 95% confidence interval (CI 0.77-0.99) in children with CP. 4- valid.
At the baseline (before treatment starts) and 6 weeks (at the end of the treatment)
Change from Baseline Trunk Control Measurement scale at 6 weeks
Time Frame: At the baseline (before treatment starts) and 6 weeks (at the end of the treatment)

It measures the trunk control level as it helps in differentiating between children who are independent in self-care and mobility and those who are not, it is valid, and it has a good reliability in children with neurological disorders.

Trunk control Measurement Scale (TCMS) is an objective outcome measure to score trunk ability in sitting. It does consists of static and dynamic sitting balance; the latter is divided into selective movement control and dynamic reaching. The maximum value is 58 and the minimum is 0. Higher values correlate to better outcomes.
At the baseline (before treatment starts) and 6 weeks (at the end of the treatment)

Collaborators and Investigators

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

Sponsor

Alya Abdelghafour Alkhajeh

Investigators

  • Principal Investigator: Fatma Hegazy, UOS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

June 19, 2022

First Submitted That Met QC Criteria

June 30, 2022

First Posted (Actual)

July 5, 2022

Study Record Updates

Last Update Posted (Actual)

July 5, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U19102427

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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