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

Study 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.

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

Conditions
-----------------
Hemorrhagic Stroke, Ischemic Stroke, Rehabilitation

Intervention / Treatment
-----------------
* Other: short-intensity modified CIMT and conventional therapy
* Other: conventional therapy alone


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be allocated into two groups by randomization. The experimental group in which patients will be given short-intensity mCIMT along with conventional therapy. A control group, in which patients will be given conventional therapy alone. The therapy regime will be 3 hours/ day, 5 days/week, and 4 successive weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>an experimental group receiving short-intensity modified CIMT and conventional therapy | Other: short-intensity modified CIMT and conventional therapy<br>* an experimental group receiving short-intensity modified CIMT and conventional therapy<br>|
| Active Comparator: control group<br>a control group receiving conventional therapy alone. | Other: conventional therapy alone<br>* a control group receiving conventional therapy alone.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf motor function test (WMF) | 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. | 9 months | 
| The motor activity log | 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. | 9 months | 
| The Ashworth scale, | 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. | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemorrhagic Stroke, Ischemic Stroke, Rehabilitation