Comparative Effects of Intensive and Distributed CIMT on Upper Extremity Function in Stroke Patients

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: Intensive constraint-induced movement therapy; Other: Distributed constraint-induced movement therapy

• Registration Number: NCT06459336
• Lead Sponsor: Riphah International University

Brief Summary

The main question this clinical trial is aims to answer is whether intensive and distributed constraint-induced movement therapy has similar effects on upper extremity function in participants with stroke. Participants will receive intensive protocol of CIMT for 6 hours for 6 days to make total of 36 hours while distributed protocol participants will receive 2.25 hours of training two times a week for 8 weeks making total of 36 hours.

Detailed Description

Many studies have examined the effects of constraint-induced movement therapy (CIMT) in upper extremity function in stroke patients. Literature has shown effectiveness of different CIMT protocols for stroke patients. Emerging research have demonstrated comparative efficacy of constraint-induced movement therapy with different physical therapy approaches i.e. bimanual intensive training, motor relearning programme for improving upper extremity function. But according to researcher's knowledge, the gap of current knowledge is that no study has directly investigated the comparative effectiveness of intensive and distributed CIMT in stroke patients and if intensive and distributed CIMT had similar motor outcomes in upper limb function after stroke

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-11
• Last Update Submitted: 2024-06-11
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age 40-70 years
• ischemic or hemorrhagic stroke
• Both genders eligible
• Gcs score ≥ 13
• Able to extend at least 10° at the fingers
• Able to extend at least 20° at the wrist
• Patients diagnosed with one side more affected(hemiplegia)
• Modified Ashworth scale score ≤2

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Exclusion Criteria

• severe, chronic systemic illness
• Epilepsy
• History of fall past 6 months
• Injections of botulinum toxin type A or operations on the UE within 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive constraint-induced movement therapy	Intensive constraint-induced movement therapy	intensive protocol of CIMT of total 36 hours will be given in a week
Distributed constraint-induced movement therapy	Distributed constraint-induced movement therapy	Distributed participants will total of 36 hours treatment for 8 weeks

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment-Upper Extremity	8th week	It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. It consists of 30 items assessing motor function and 3 items assessing reflex function. The score most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal" (total score range, 0-66).
Wolf motor function test	8th week	This test was designed to assess the motor ability of patients with moderate to severe upper extremity motor deficits in the laboratory and clinic. The original version of this test was developed by Dr. Steven L. Wolf, Emory University School of Medicine. The original version consisted of 21 items; the widely used version of the wolf motor function test consists of 17 items. it uses a Uses a 6-point ordinal scale i.e."0" means "does not attempt with the involved arm" to "5" means "arm does participate; movement appears to be normal."

Trial Locations

Locations (1)

Hameed Latif Hospital; 🇵🇰 Lahore, Punjab, Pakistan