Effects of Upperlimb Sensorimotor Training in Hemiplegic Cerebral Palsy

January 28, 2024 updated by: Riphah International University
The study aims to determine the effects of upper limb sensorimotor training as compared to task oriented raining in subjects with cerebral palsy. The study will target the upperlimb functions using multiple outcomes and will find the changes in subjects undergoing sensorimotor or task oriented training.

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

The stduy will include subjects fulfilling the inclusion criteria, will be divided into 2 groups; interventional and control. The interventional group will be recieving sensorimotor training comprising of sensory activities and motor activities. The control group will be having motor activities in the form of task oriented training. The duration of intervention would be 40 minutes in each group, 3 days a week, for 8 weeks.

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.
44

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Islamabad Capital Territory
      • Islamabad, Islamabad Capital Territory, Pakistan, 44000
        • Alfarabi Special Education Centre/ Physical Health Centre

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hemiplegic cerebral palsy Modified Ashworth scale score 2 and 3

Exclusion Criteria:

  • Other neurological disorders Previous upper limb surgeries Botox injection in last 1 year

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.
Experimental: interventional group

Superficial and Deep Sensory training: 5 sets of 9 min, 3 times a week for 8 weeks.

Motor training: 5 sets of 9 min, 3 times a week for 8 weeks. Conventional therapy: 30 min, 3 days for 8 weeks
Other: Sensory training
sensory training includes superficial sensory and deep sensory activities i.e. play with dough, painting with finger, recognizing objects with blocked vision, recognizing the drawn figure on palm, oint compression, bearing the weight on the paretic hand, leaning on the paretic side, walking with hand, rolling the heavy objects, dough squeezing etc.
Other: Motor training
Motor training would involve activitoes such as throwing and catching a ball, targeted ball throwing, hand in hand ball transferring, ball rolling, hitting a ball to ground and wall, hand roller etc.
Other: Conventional exercises
stretching exercises, muscle strengthening exercises, static weight bearing exercises, positioning
Active Comparator: control group
Motor training: 5 sets of 9 min, 3 times a week for 8 weeks. Conventional therapy: 30 min, 3 days for 8 weeks
Other: Motor training
Motor training would involve activitoes such as throwing and catching a ball, targeted ball throwing, hand in hand ball transferring, ball rolling, hitting a ball to ground and wall, hand roller etc.
Other: Conventional exercises
stretching exercises, muscle strengthening exercises, static weight bearing exercises, positioning

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
Modified Ashworth Scale (MAS)
Time Frame: Baseline
Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
Baseline
Modified Ashworth Scale (MAS)
Time Frame: After 4 weeks
Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
After 4 weeks
Modified Ashworth Scale (MAS)
Time Frame: After 8 weeks
Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
After 8 weeks
Finger Joint Position Sense
Time Frame: Baseline
Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
Baseline
Finger Joint Position Sense
Time Frame: After 4 weeks
Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
After 4 weeks
Finger Joint Position Sense
Time Frame: After 8 weeks
Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
After 8 weeks
Manual ability classification system
Time Frame: Baseline
Manual ability classification system is used to determine daily use hand activities
Baseline
Manual ability classification system
Time Frame: After 4 weeks
Manual ability classification system is used to determine daily use hand activities
After 4 weeks
Manual ability classification system
Time Frame: After 8 weeks
Manual ability classification system is used to determine daily use hand activities
After 8 weeks
Manual Muscle Testing
Time Frame: Baseline
Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
Baseline
Manual Muscle Testing
Time Frame: After 4 weeks
Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
After 4 weeks
Manual Muscle Testing
Time Frame: After 8 weeks
Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
After 8 weeks
Abilities of Hand (ABILHAND-KIDS)
Time Frame: Baseline
This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
Baseline
Abilities of Hand (ABILHAND-KIDS)
Time Frame: After 4 weeks
This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
After 4 weeks
Abilities of Hand (ABILHAND-KIDS)
Time Frame: After 8 weeks
This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
After 8 weeks
Pediatric Arm Function Test
Time Frame: Baseline
This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
Baseline
Pediatric Arm Function Test
Time Frame: After 4 weeks
This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
After 4 weeks
Pediatric Arm Function Test
Time Frame: After 8 weeks
This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
After 8 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.
Riphah International 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: Kiran Khushnood, MSNMPT, Riphah International 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.
September 20, 2023

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 20, 2024

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 25, 2024

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).
August 21, 2023

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.
August 21, 2023

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.
August 25, 2023

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.
January 30, 2024

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.
January 28, 2024

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.
January 1, 2024

More Information

Terms related to this study

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.
  • RIPHAH/FR&AHS/Letter-014194

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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