- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07244146
Effects of CHRIST Among Children With Spastic CP
Effects of Comprehensive Hand Intense Strength Training on In Hand Manipulation and Grip Strength Among Children With Spastic Cerebral Palsy
This Quasi experimental study investigates the effects of CHRIST on In Hand Manipulation and Grip Strength amonfg children with Spastic Cerebral Palsy. The study involves 14 children from 6-12 years of age, and will be given intervention for 10 weeks period.
Key performance outcomes- In Hand Manipulation and Grip Strength will be assessed both before and after the intervention. This study aims to address this gap by evaluating the effects of the CHRIST on IHM and grip strength in children diagnosed with spastic cerebral palsy. The hypothesis is that integrating strength training with high repetition, functionally relevant tasks yields greater and more practical gains than strength training or conventional therapy alone. Data will be analyzed through SPSS version 27.0
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed, MSPT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 5400
- Recruiting
- Imran Amjad
-
Contact:
- Muhmmad Asif Javed, MS
- Phone Number: 033224209422
- Email: a.javed@ripah.edu.pk
-
Contact:
- Fairy Ali, MS*
- Phone Number: 03314307661
- Email: fairyali@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children Diagnosed with hemiplegic spastic cerebral palsy.
- Age 6-12 years.
- Capable of following commands regarding hand use and testing.
- Capable of communicating needs.
- Parents or caregivers willing to provide informed consent and participate in the study.
- No contraindications to moderate physical activity.
- Able to lift the more affected arm 15 cm above a table surface and grasp light objects
Exclusion Criteria:
- Children with musculoskeletal system injuries, including upper limb fractures or contractures, as well as those who had received medications affecting muscle strength or spasticity, were excluded from the study.
- Orthopedic surgery involving the more affected hand within the past 6 months.
- Children with Cardiovascular disease.
- Lack of cooperation with instructions or other behavioral challenges that prevent effective delivery of intensive therapy.
- Visual impairments that may hinder active participation.
- Seizure or family history of seizure disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The intervention will be comprehensive hand repetitive intense strength training
CHRIST, is a treadmill-based training with body weight supported by the upper limbs.
There will be a session of 40 minutes, which includes 3 sets (10 minutes exercise with 3 minutes rest period per set), three times a week, over a 10 week period.
By maintaining the posture of the quadruped, the abdomen and weight of the lower limb will be supported by using a support board under the abdomen.
The speed of the treadmill for the upper limbs will be 0.3-1.2
km/h.
Results will be evaluated by MA2 and dynamometer.
|
CHRIST, is a treadmill-based training with body weight supported by the upper limbs.
There will be a session of 40 minutes, which includes 3 sets (10 minutes exercise with 3 minutes rest period per set), three times a week, over a 10 week period.
By maintaining the posture of the quadruped, the abdomen and weight of the lower limb will be supported by using a support board under the abdomen.
The speed of the treadmill for the upper limbs will be 0.3-1.2
km/h.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Jamma Dynamometer
Time Frame: Baseline, 1st week and 10th week
|
Grip strength will be measured by Jammar Dynamometer.
The hand-held dynamometer are reliable measurement instruments to measure muscle strength of the arm and hand in children with unilateral spastic cerebral palsy, aged 7 12 years
|
Baseline, 1st week and 10th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Melbourne assessment 2 (MA2)
Time Frame: Baseline, 1st week and 10th week
|
Melbourne Assessment 2 (MA2) will be used to assess in-hand manipulation before and after the intervention (CHRIST) to evaluate the impact.
MA2 is a reliable and valid tool for assessment of upper limb in children with CP.
|
Baseline, 1st week and 10th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: FAIRY ALI, MSPT, 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/FAIRY ALI
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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