- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06748235
Comprehensive Hand Repetation Intensive Strength Training on Upper Limb in Children With Cerebral Palsy (CHRIST)
Effects of Comprehensive Hand Repetition Intensive Strength Training on Upper LIMB Function in Children With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Comprehensive Hand Repetitive Intensive Strength Training (CHRIST) program is designed to provides special training for enhancing muscular strength of the upper limb.
The current study will be a randomized control trial, and data will be collected from Ittefaq Hospital Lahore Pakistan. The study will include 30 patients equally divided into two groups experimental group included 15 patients, and the control group included 15 patients and was randomly allocated. The inclusion criteria for the study will be Comprehensive Hand Repetitive Intensive Strength Training on the upper limb of CP patients with age between 6 to 12 years and both genders will be included children who have normal communication skills and cognitive function will be included and give 30 minutes per session three sessions in a week and total 30 sessions per ten weeks and to normalize muscle tone and patient able to perform ADLS.
Children having damaged musculoskeletal system including fracture of upper limb and contracture will be excluded children having undergone administration of medicine influencing muscular strength and spasticity will be excluded tools used for data collection are Jebsen-Taylor Hand Function Test and ABIL Hand for upper limb and data will be analyzed by SPSS version 26.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Asif Javed, MS
- Phone Number: 03224209422
- Email: a.javed@riphah.edu.pk
Study Contact Backup
- Name: Imran Amjad Dr, PhD
- Phone Number: 9233224390125
- Email: Imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Recruiting
- Riphah International University
-
Contact:
- Muhammad Asif Javed, MS
- Phone Number: 03224209422
- Email: a.javed@riphah.edu.pk
-
Contact:
- IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
-
Principal Investigator:
- Nisha Feroz, MS
-
Lahore, Punjab, Pakistan
- Recruiting
- Riphah International University
-
Contact:
- Muhammad Asif Javed, MS
- Phone Number: 03224209422
- Email: a.javed@riphah.edu.pk
-
Contact:
- IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
-
Principal Investigator:
- Nisha Feroz, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages 6 to 12 years will be included
- Both genders will be included
- GMFCS I and II
- Children who have normal communication skills and cognitive functions will be included
Exclusion Criteria:
- Children having damage to the musculoskeletal system including fracture of the upper limb and contracture will be excluded
- Children who have undergone the administration of medicine influencing muscular strength and spasticity will be excluded
Study Plan
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: Experimental group will received Comprehensive Hand Repetitive Intensive Strength Training
Physical Therapy 60 minutes per session, three sessions a week, at a total of 30 sessions per ten weeks.
Comprehensive hand repetitive intensive strength training included treadmill training for the upper limb with body weight supporting the using upper limb.
The posture of an arm swing was to maintain the joints of the elbows and wrist as much as possible, and the shoulder joint was allowed to be flexed by 160 degrees.
|
Comprehensive Hand Repetitive Intensive Strength Training and Routine Physical Therapy 60 minutes per session, three sessions a week, at a total of 30 sessions per ten weeks.
Comprehensive hand repetitive intensive strength training included treadmill training for the upper limb with body weight supporting the using upper limb.
The posture of an arm swing was to maintain the joints of the elbows and wrist as much as possible, and the shoulder joint was allowed to be flexed by 160 degrees .The posture of the arm stance supported the weight using metacarpal heads, hands, and elbows, and the shoulder joints were allowed to be flexed by 90 degrees.
|
|
Other: Routine Physical Therapy
control will received 60 minutes per a session, three sessions a week, at a total of 30 sessions per 10 weeks by creating a home program, which consisted of a total of 8 exercises that enhanced the muscular strength of the upper limb including the triceps brachii and extensor carpi radialis, and conveyed an effect of reaching the muscles out.
|
Received 60 minutes per a session, three sessions a week, at a total of 30 sessions per 10 weeks by creating a home program, which consisted of a total of 8 exercises that enhanced the muscular strength of the upper limb including the triceps brachii and extensor carpi radialis, and conveyed an effect of reaching the muscles out.
flexion and extension muscle strengthening with towel, hand grip and wrist extension muscle strengthening This exercise consisted of shoulder extension muscle, elbow flexion muscle, shoulder abduction muscle, and elbow extension muscle strengthening with a thera band, as well as hand grip, forearm with a velcro board, wrist extension muscle strengthening with sandbag and shoulder abduction-extension muscle strengthening with a thera band.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Jebsen-Taylor Hand Function Test (JTHFT)
Time Frame: 15 to 30 minutes
|
The Jebsen-Taylor Hand Function Test (JTHFT) is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).
The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, stimulated tree feeding, stacking, and lifting large, lightweight, and heavy objects.
[JTHFT finds easy applicability in clinical settings since it can be administered in a short time by using readily available materials.
Several studies report that the JTHFT is a valid assessment tool for the measurement of hand dysfunctions from a variety of patient populations having high reliability were (0.84-0.94 )
|
15 to 30 minutes
|
|
ABIL HAND
Time Frame: 10 - 20 minutes
|
ABILHAND-Kids Survey, which evaluates upper extremity function in children with cerebral palsy ABILHAND-Kids survey evaluates the bilateral upper extremities of children, and which has proven validity and reliability were 0.96 and 0.70 , including 21 questions for families related to the common tasks undertaken by their children in their daily living activities.
The ABILHAND-Kids survey was originally developed in French as a standard means of assessment of manual ability in children with CP.
This survey evaluates the most typical indicators of manual activity, in which some of the items were developed based on the ABILHAND-Kids survey, which was developed to assess manual ability in adult patients, while other items were selected from existing scales or were adapted to broaden the variability of activities
|
10 - 20 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nisha Feroz, MS, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR/AHS/24/NISHA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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