Effects of Modified CIMT With and Without PNF

NCT07244042 | Recruiting DMC

• 1 other identifier: REC/RCR&AHS/MAIDA SHABBIR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial investigates the effects of modified CIMT with and without the addition of PNF techniques on upper extremity function in pediatric stroke patients, aiming to determine whether combining these approaches yields superior motor recovery.This study will be conducted as a randomized clinical trial over an intervention period of six-week. 20 pediatric stroke patients with upper extremity impairments will be randomly assigned to two groups: one receiving modified CIMT alone and the other receiving modified CIMT combined with PNF techniques. Pre- and post-intervention assessments will be conducted using standardized measures, such as Pediatric Motor Activity Log(PMAL) for upper extremity function, Modified Ashworth Scale(MAS) and Manual Ability Classification System(MACS). Muscle tone and physical activity status will also be evaluated. Data will be entered and analyzed in SPSS V-26.0 to compare improvements in motor function between the two groups, with statistical significance assessed to determine the efficacy of each intervention

Conditions

Pediatric Stroke

Keywords

Modified CIMT; Proprioceptive Neuromuscular Facilitation(PNF); Pediatric Stroke

Outcome Measures

Primary Outcomes (3)

• Pediatric Motor Activity Log (PMAL)

  This log will be used to assess the spontaneous use of the affected upper limb in daily activities. Parents/guardians will rate the frequency and quality of use.

  Base line, 3rd Week, 6th week

• Modified Ashworth Scale (MAS)

  This scale will be used to assess the degree of spasticity in the affected upper limb.

  Base line, 3rd Week, 6th week

• Manual Ability Classification System (MACS)

  The MACS will classify the participant's ability to handle objects and perform manual tasks in daily activities.

  Base line, 3rd Week, 6th week

Study Arms (2)

Group A: Intervention Group (Modified CIMT+PNF)

ACTIVE COMPARATOR

Modified CIMT: Constraining the unaffected arm with a mitt or splint to encourage use of the affected arm (3-5 times a week). PNF Techniques: Includes rhythmic initiation, combination of isotonics, and replication exercises to enhance proprioception and motor control in the affected arm (10 reps of each technique for 15-20 minutes with rest interval) Rest Interval for 1-2 minute to prevent fatigue Routine Physiotherapy Exercises: Targeted exercises focusing on strength, range of motion, and coordination. * Strengthening: 3 sets of 10-12 reps per targeted muscle group (e.g., biceps, wrist extensors). * Range of Motion (ROM): 10-15 repetitions per joint (e.g., shoulder, elbow, wrist). * Coordination and Functional Training: Structured tasks such as reaching and grasping toys or objects for 15-20 minutes. Duration: 6 weeks

Other: Modified CIMT; Other: Proprioceptive Neuromuscular Facilitation

Group B: Control Group (Modified CIMT only)

ACTIVE COMPARATOR

Warm-Up Exercises: 10-15 minutes of light exercises for the affected arm, focusing on gentle range of motion. Modified CIMT: Constraining the unaffected arm with a mitt or splint to promote use of the affected arm(3-5 times a week). Routine Physiotherapy Exercises: Targeted exercises focusing on strength, range of motion, and coordination. * Strengthening: 3 sets of 10-12 reps per targeted muscle group (e.g., biceps, wrist extensors). * Coordination and Functional Training: Structured tasks such as reaching and grasping toys or objects for 15-20 minutes. Duration: 6 week

Other: Modified CIMT

Interventions

Modified CIMT OTHER

Modified CIMT Protocol: Participants wear a mitt on the unaffected hand daily for 5 hours approximately to encourage the use of the affected upper limb. They engage in task-oriented activities designed to improve motor function, hand-eye coordination, and strength of the affected extremity.

Group A: Intervention Group (Modified CIMT+PNF); Group B: Control Group (Modified CIMT only)

Proprioceptive Neuromuscular Facilitation OTHER

PNF (Proprioceptive Neuromuscular Facilitation) is a stretching and rehabilitation technique that combines muscle contraction and relaxation with passive stretching to improve flexibility, range of motion, and muscle control

Group A: Intervention Group (Modified CIMT+PNF)

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Paeds Patients with confirmed diagnosis of Stroke
• Children between age 5 to 13 years
• Modified Ashworth Scale spasticity level 1 and 2.
• Patients having Manual Ability Classification System Score between 3 to 6.
• GMFCS level 1 and 2
• Patient having in affected upper extremity at least 20◦ of active wrist extension starting from the full flexion, 10◦ of active extension or abduction in the thumb, and 10◦ of active extension in the metacarpophalangeal and interphalangeal joints of the other fingers

You may not qualify if:

• Patients with epilepsy or seizure disorder
• Patients with history of botulinum toxin injection, cognitive impairment, fracture and any surgical procedure in upper extremity

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Imran Amjad

Lahore, Punjab Province, 5400, Pakistan

RECRUITING

Related Publications (2)

• Saygili F, Guclu-Gunduz A, Eldemir S, Eldemir K, Ozkul C, Gursoy GT. Effects of modified-constraint induced movement therapy based telerehabilitation on upper extremity motor functions in stroke patients. Brain Behav. 2024 Jun;14(6):e3569. doi: 10.1002/brb3.3569.

  PMID: 38873866 BACKGROUND

• Adiguzel H, Kirmaci ZIK, Gogremis M, Kirmaci YS, Dilber C, Berktas DT. The effect of proprioceptive neuromuscular facilitation on functional skills, muscle strength, and trunk control in children with cerebral palsy: A randomized controlled trial. Early Hum Dev. 2024 May;192:106010. doi: 10.1016/j.earlhumdev.2024.106010. Epub 2024 Apr 15.

  PMID: 38653163 BACKGROUND

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maida Shabbir, MS-PT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IMRAN AMJAD, PhD

CONTACT

9233224390125; imran.amjad@riphah.edu.pk

Muhammad Asif Javed, MS-PT

CONTACT

923224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask the both groups about the treatment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be conducted as a randomized clinical trial over an intervention period of six-week. 20 pediatric stroke patients with upper extremity impairments will be randomly assigned to two groups: one receiving modified CIMT alone and the other receiving modified CIMT combined with PNF techniques. Pre- and post-intervention assessments will be conducted using standardized measures, such as Pediatric Motor Activity Log(PMAL) for upper extremity function, Modified Ashworth Scale(MAS) and Manual Ability Classification System(MACS). Muscle tone and physical activity status will also be evaluated. Data will be entered and analyzed in SPSS V-26.0 to compare improvements in motor function between the two groups, with statistical significance assessed to determine the efficacy of each intervention.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: October 27, 2025
• Primary Completion: January 25, 2026
• Study Completion: February 10, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)