Effects of Modified CIMT With and Without PNF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-27

Study Completion Date

2026-02-10

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Pediatric Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Participants will get separate treatment protocols and possible efforts will be put to mask the both groups about the treatment

Study Groups

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Group A: Intervention Group (Modified CIMT+PNF)

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

Group Type ACTIVE_COMPARATOR

Modified CIMT

Intervention Type 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.

Proprioceptive Neuromuscular Facilitation

Intervention Type 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 B: Control Group (Modified CIMT only)

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

Group Type ACTIVE_COMPARATOR

Modified CIMT

Intervention Type 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.

Interventions

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Modified CIMT

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.

Intervention Type OTHER

Proprioceptive Neuromuscular Facilitation

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No