- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07441057
Effects of CHRIST on Upper Limb Function in Children With Pediatric Stroke
Effects of Comprehensive Hand Repetitive Intense Strength Training on Upper Limb Function in Children With Pediatric Stroke
Pediatric stroke poses significant challenges due to its impact on a child's developing brain. Both ischemic and hemorrhagic strokes in children can result in long-term motor, sensory, and cognitive impairments, particularly affecting upper limb function.
Comprehensive Hand Repetitive Intensive Strength Training is a structured intervention model that integrates high-repetition, strength-based, and goal-oriented exercises targeting upper limb coordination and use. This study aims to explore the efficacy of CHRIST in improving upper limb function using the ABILHAND-Kids questionnaire to assess changes in manual ability. The study aims to generate pediatric-specific evidence for intensive hand-focused rehabilitation strategies.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Mandi Bahāuddīn, Punjab Province, Pakistan, 5400
- Recruiting
- Clinical settings having pediatric stroke patients.
-
Contact:
- Mashar Hayat, MS
- Phone Number: 03338264018
- Email: docmashar@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Children aged 7 to 12 years diagnosed with pediatric ischemic or hemorrhagic stroke(21).
- Clinical evidence of upper limb motor impairment following stroke.
- Parent/guardian consent and child assent obtained.
Exclusion Criteria:
Severe cognitive or behavioral impairments interfering with therapy.
- Uncontrolled seizures or medical conditions contraindicating exercise.
- Previous participation in intensive upper limb therapy within the last 3 months.
- Orthopedic conditions (e.g., fractures, contractures) that limit upper limb movement.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CHRIST will be given to childrenwith pediatric stroke
|
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 weeks period.
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 |
|---|---|---|
|
ABILHAND-Kids
Time Frame: Baseline and after 10 weeks
|
The ABILHAND-Kids is specifically developed to evaluate upper limb function in children and adolescents with neurological impairments, making them highly sensitive to changes in motor performance
|
Baseline and after 10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mashar Hayat, MS, Riphah International University, Lahore
Publications and helpful links
General Publications
- Amlie-Lefond C, Sebire G, Fullerton HJ. Recent developments in childhood arterial ischaemic stroke. Lancet Neurol. 2008 May;7(5):425-35. doi: 10.1016/S1474-4422(08)70086-3.
- Kim DA, Lee JA, Hwang PW, Lee MJ, Kim HK, Park JJ, You JH, Lee DR, Lee NG. The Effect of Comprehensive Hand Repetitive Intensive Strength Training (CHRIST) Using Motion Analysis in Children with Cerebral Palsy. Ann Rehabil Med. 2012 Feb;36(1):39-46. doi: 10.5535/arm.2012.36.1.39. Epub 2012 Feb 29.
- Kabir R, Sunny MSH, Ahmed HU, Rahman MH. Hand Rehabilitation Devices: A Comprehensive Systematic Review. Micromachines (Basel). 2022 Jun 29;13(7):1033. doi: 10.3390/mi13071033.
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
- Zurriat Fatima
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
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