Effects of Modified CIMT With and Without PNF

Riphah International University

Status: Enrolling

Conditions: Pediatric Stroke

Treatments: Other: Modified CIMT; Other: Proprioceptive Neuromuscular Facilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT07244042

REC/RCR&AHS/MAIDA SHABBIR

Details and patient eligibility

About

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

Full description

Pediatric stroke often results in impaired upper extremity function, significantly affecting children's ability to perform daily tasks and reducing their overall quality of life. Traditional therapeutic approaches may not provide sufficient recovery, necessitating the exploration of more effective interventions. Constraint-Induced Movement Therapy (CIMT) has been shown to improve motor function in pediatric stroke patients by enhancing the use of the affected limb. However, incorporating Proprioceptive Neuromuscular Facilitation (PNF) techniques may enhance the outcomes further by stimulating neuromuscular pathways to improve strength and coordination. The objective of this study is to compare 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 impair-ents 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 5 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Group A: Intervention Group (Modified CIMT+PNF)

Active Comparator group

Description:

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

Treatment:

Other: Proprioceptive Neuromuscular Facilitation

Other: Modified CIMT

Group B: Control Group (Modified CIMT only)

Active Comparator group

Description:

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

Treatment:

Other: Modified CIMT