- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06011616
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
44
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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 |
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.
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.
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
|
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.
stretching exercises, muscle strengthening exercises, static weight bearing exercises, positioning
|
What is the study measuring?
Primary Outcome Measures
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
Investigators
- 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)
September 20, 2023
Primary Completion (Actual)
January 20, 2024
Study Completion (Actual)
January 25, 2024
Study Registration Dates
First Submitted
August 21, 2023
First Submitted That Met QC Criteria
August 21, 2023
First Posted (Actual)
August 25, 2023
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 28, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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