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NCT Number: NCT07244042

Effects of Modified CIMT With and Without PNF

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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Key information

Conditions

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imran Amjad

Lahore, Punjab Province, 5400, Pakistan

Location status: Recruiting

Location contact

Maida Shabbir, MS*

CONTACT

Muhmmad Asif Javed, MS

CONTACT

[email protected]

033224209422

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Pediatric Motor Activity Log (PMAL)

    Time frame: Base line, 3rd Week, 6th week

    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.

  2. Modified Ashworth Scale (MAS)

    Time frame: Base line, 3rd Week, 6th week

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

  3. Manual Ability Classification System (MACS)

    Time frame: Base line, 3rd Week, 6th week

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

Study contacts

Contact information is provided by the study sponsor or research team.

IMRAN AMJAD, PhD

CONTACT

[email protected]

9233224390125

Muhammad Asif Javed, MS-PT

CONTACT

[email protected]

923224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Modified Constraint-induced Movement Therapy With and Without Proprioceptive Neuromuscular Facilitation Techniques on Upper Extremity Function in Pediatric Stroke Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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