The Effectiveness of Upper Extremity Isokinetic Strengthening in Post-stroke Hemiplegia

Study Overview
=================
Brief Summary
-----------------
This randomised controlled study will investigate the effectiveness of isokinetic strengthening on the upper extremity functionality and strength in post-stroke hemiplegic patients.

Official Title
-----------------
The Effectiveness of Upper Extremity Isokinetic Strengthening in Post-stroke Hemiplegia

Conditions
-----------------
Stroke Rehabilitation, Hemiplegia

Intervention / Treatment
-----------------
* Device: isokinetic strengthening
* Other: exercise band strengthening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active motion in upper extremity Brunnstrom's Scale above 3 Exclusion Criteria: Unstable medical conditions Cognitive problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: isokinetic<br> | Device: isokinetic strengthening<br>* isokinetic upper extremity (forearm) strengthening for 4 weeks 3d/w<br>|
| Active Comparator: exercise band<br> | Other: exercise band strengthening<br>* upper extremity (forearm) strengthening with exercise band 4 weeks 3d/w<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| upper extremity strength | Muscles: forearm flexors and extensors Measurement tool: MicroFET3 (Hoggan Health Industries Inc. West Jordan, UT, USA) | 0, 4, 8 weeks (change from baseline upper extremity strength at 4 weeks and at 8 weeks will be assessed) | 
| pik torque | Muscles: wrist flexors and extensors Measurement Tool: CSMI Humac Norm Cybex isokinetic dinamometer (HUMAC® /2009 Version: 10.000.0065, Computer Sports Medicine Inc., USA) | 0, 4, 8 weeks (change from baseline pik torque at 4 weeks and at 8 weeks will be assessed) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hand grip strength | Measurement tool: Jamar Hydraulic Hand Dynamometer (Patterson Medical, Warrenville, IL, USA) | 0, 4, 8 weeks | 
| Fugl-Meyer Assessment scale for upper extremity | Scale range: 0-66; higher values represent a better outcome; subscales are combined by summing to compute a total score | 0, 4, 8 weeks | 
| Disabilities of the arm, shoulder and hand questionnaire (Part 1) | Scale range: 0-100; higher scores represent more disabilities of the upper limb; Total score (sum of the scores for 30 questions) is put in a formula to compute the DASH disability score | 0, 4, 8 weeks | 
| Stroke Impact Scale version 3.0 | Includes 8 domains and an extra assessment for stroke recovery; scores range 0-100 for each domain; higher scores represent better outcome; a formula is used for scoring each domain. | 0, 4, 8 weeks |