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

Primary Purpose

Stroke Rehabilitation, Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
isokinetic strengthening
exercise band strengthening
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Rehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Active motion in upper extremity
  • Brunnstrom's Scale above 3

Exclusion Criteria:

  • Unstable medical conditions
  • Cognitive problems

Sites / Locations

  • İlke COŞKUN BENLİDAYI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

isokinetic

exercise band

Arm Description

Outcomes

Primary Outcome Measures

upper extremity strength
Muscles: forearm flexors and extensors Measurement tool: MicroFET3 (Hoggan Health Industries Inc. West Jordan, UT, USA)
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)

Secondary Outcome Measures

hand grip strength
Measurement tool: Jamar Hydraulic Hand Dynamometer (Patterson Medical, Warrenville, IL, USA)
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
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
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.

Full Information

First Posted
January 6, 2019
Last Updated
January 24, 2020
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT03834311
Brief Title
The Effectiveness of Upper Extremity Isokinetic Strengthening in Post-stroke Hemiplegia
Official Title
The Effectiveness of Upper Extremity Isokinetic Strengthening in Post-stroke Hemiplegia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation, Hemiplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
isokinetic
Arm Type
Experimental
Arm Title
exercise band
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
isokinetic strengthening
Intervention Description
isokinetic upper extremity (forearm) strengthening for 4 weeks 3d/w
Intervention Type
Other
Intervention Name(s)
exercise band strengthening
Intervention Description
upper extremity (forearm) strengthening with exercise band 4 weeks 3d/w
Primary Outcome Measure Information:
Title
upper extremity strength
Description
Muscles: forearm flexors and extensors Measurement tool: MicroFET3 (Hoggan Health Industries Inc. West Jordan, UT, USA)
Time Frame
0, 4, 8 weeks (change from baseline upper extremity strength at 4 weeks and at 8 weeks will be assessed)
Title
pik torque
Description
Muscles: wrist flexors and extensors Measurement Tool: CSMI Humac Norm Cybex isokinetic dinamometer (HUMAC® /2009 Version: 10.000.0065, Computer Sports Medicine Inc., USA)
Time Frame
0, 4, 8 weeks (change from baseline pik torque at 4 weeks and at 8 weeks will be assessed)
Secondary Outcome Measure Information:
Title
hand grip strength
Description
Measurement tool: Jamar Hydraulic Hand Dynamometer (Patterson Medical, Warrenville, IL, USA)
Time Frame
0, 4, 8 weeks
Title
Fugl-Meyer Assessment scale for upper extremity
Description
Scale range: 0-66; higher values represent a better outcome; subscales are combined by summing to compute a total score
Time Frame
0, 4, 8 weeks
Title
Disabilities of the arm, shoulder and hand questionnaire (Part 1)
Description
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
Time Frame
0, 4, 8 weeks
Title
Stroke Impact Scale version 3.0
Description
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.
Time Frame
0, 4, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Active motion in upper extremity Brunnstrom's Scale above 3 Exclusion Criteria: Unstable medical conditions Cognitive problems
Facility Information:
Facility Name
İlke COŞKUN BENLİDAYI
City
Adana
ZIP/Postal Code
01330
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33765633
Citation
Kerimov K, Coskun Benlidayi I, Ozdemir C, Gunasti O. The Effects of Upper Extremity Isokinetic Strengthening in Post-Stroke Hemiplegia: A Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2021 Jun;30(6):105729. doi: 10.1016/j.jstrokecerebrovasdis.2021.105729. Epub 2021 Mar 23.
Results Reference
derived

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

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