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Clinical Trials/NCT05916885
NCT05916885
Completed
Not Applicable

Effects of Short-intensity Modified Constraint-induced Movement Therapy on Hand Function in Stroke Patients.

Riphah International University1 site in 1 country38 target enrollmentNovember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemorrhagic Stroke
Sponsor
Riphah International University
Enrollment
38
Locations
1
Primary Endpoint
The motor activity log
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

To determine effects of short-intensity modified constraint-induced movement therapy on hand function in stroke patients.

Detailed Description

The aim of the study is to determine the effects of a short-intensity modified CIMT (mCIMT) program on hand function in stroke patients. This study will be a randomized controlled trial comprising two groups, an experimental group in which patients will be given short-intensity mCIMT along with conventional therapy. A control group, in which participants will be given conventional therapy alone. Patients will be assessed with the Wolf Motor Function Test, the Motor Activity Log, and the Ashworth Scale before and after treatment. The data will be analyzed by using SPSS for windows software version 25. Statistical significance will be set at p=0.05.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
September 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients having the First stroke either ischemic or hemorrhagic (3-24 months after stroke)
  • Patients having Mini-mental status examination score (MMSE) ≤23/30
  • Patients having Passive range of motion (PROM) includes at least 90 degrees shoulder flexion and abduction, 45degrees shoulder external rotation,- 30 degrees elbow extension, and 45 degrees forearm supination and pronation (from a neutral position). At least 10 degrees active wrist extension, 10 degrees abduction/thumb extension, and 10-degree extension at the level of the metacarpophalangeal and interphalangeal joints between the two toes among the II-III-IV-V fingers (these movements will be repeated starting from a resting position 3 times in 1 minute).

Exclusion Criteria

  • Patients having Subarachnoid hemorrhage.
  • Patients having Motor activity log - the amount of use score ≥2.5
  • Patients having treatment of upper limb spasticity (e.g., botulinum toxin) in the 3 months prior to the start of the study and/or during its execution.

Outcomes

Primary Outcomes

The motor activity log

Time Frame: 9 months

The motor activity log is a structured interview, designed to explore how and how well subjects are using the more affected arm outside of a laboratory setting. Participants are asked standardized questions about their high-impact arm usage (amount scale or AS) and quality of movement (how good scale or HW) during a specified functional activity. The scale is printed on a separate sheet and placed in front of the participant during test administration. Participants should be told that they can give half marks (i.e. 0.5, 1.5, 2.5, 3.5, 4.5) if this reflects their assessment.

Wolf motor function test (WMF)

Time Frame: 9 months

Wolf motor function test (WMF) is a new time-based method for evaluating upper extremity performance that provides insight into joint-specific and whole limb movements. To investigates the effects of mandatory exercise therapy in patients with mild to moderate stroke and traumatic brain injury. The original version of the WMFT consisted of 21 items. The widely used WMFT consists of 17 items. The first 6 items consist of timed functional tasks, items 7 and 14 measure muscle strength, and the remaining 9 items consist of analyses of the quality of movement in accomplishing various tasks.

The Ashworth scale,

Time Frame: 9 months

The Ashworth scale, which rates each passive movement between 1 (normal) and 5 (immobility), was used in a recent study and is easier to use than other methods and applicable to wide-range movements.

Study Sites (1)

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