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

January 24, 2020 updated by: Ilke Coskun Benlidayi, Cukurova University
This randomised controlled study will investigate the effectiveness of isokinetic strengthening on the upper extremity functionality and strength in post-stroke hemiplegic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01330
        • İlke COŞKUN BENLİDAYI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Unstable medical conditions
  • Cognitive problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
upper extremity strength
Time Frame: 0, 4, 8 weeks (change from baseline upper extremity strength at 4 weeks and at 8 weeks will be assessed)
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
Time Frame: 0, 4, 8 weeks (change from baseline pik torque at 4 weeks and at 8 weeks will be assessed)
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
Time Frame: 0, 4, 8 weeks
Measurement tool: Jamar Hydraulic Hand Dynamometer (Patterson Medical, Warrenville, IL, USA)
0, 4, 8 weeks
Fugl-Meyer Assessment scale for upper extremity
Time Frame: 0, 4, 8 weeks
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)
Time Frame: 0, 4, 8 weeks
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
Time Frame: 0, 4, 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2019

Primary Completion (Actual)

November 15, 2019

Study Completion (Actual)

November 15, 2019

Study Registration Dates

First Submitted

January 6, 2019

First Submitted That Met QC Criteria

February 6, 2019

First Posted (Actual)

February 7, 2019

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CukurovaPMR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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