Effects of Modified CIMT With and Without PNF

Official title

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

Overview

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

Detailed 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.

Interventions

• Other 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.
• 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

Primary outcome measures

• Pediatric Motor Activity Log (PMAL) [Time frame: Base line, 3rd Week, 6th week]
• Modified Ashworth Scale (MAS) [Time frame: Base line, 3rd Week, 6th week]
• Manual Ability Classification System (MACS) [Time frame: Base line, 3rd Week, 6th week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Pakistan · 1 center

• Imran Amjad — Lahore

Publications

• 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
• 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

Identifiers

NCT: NCT07244042 · REC/RCR&AHS/MAIDA SHABBIR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗