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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834311
Recruitment Status : Completed
First Posted : February 7, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ilke Coskun Benlidayi, Cukurova University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Rehabilitation Hemiplegia Device: isokinetic strengthening Other: exercise band strengthening Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Upper Extremity Isokinetic Strengthening in Post-stroke Hemiplegia
Actual Study Start Date : February 21, 2019
Actual Primary Completion Date : November 15, 2019
Actual Study Completion Date : November 15, 2019
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. hand grip strength [ Time Frame: 0, 4, 8 weeks ]
    Measurement tool: Jamar Hydraulic Hand Dynamometer (Patterson Medical, Warrenville, IL, USA)

  2. 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

  3. 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

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unstable medical conditions
  • Cognitive problems
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834311


Locations
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Turkey
İlke COŞKUN BENLİDAYI
Adana, Turkey, 01330
Sponsors and Collaborators
Cukurova University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ilke Coskun Benlidayi, Associate Professor, Cukurova University
ClinicalTrials.gov Identifier: NCT03834311    
Other Study ID Numbers: CukurovaPMR
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Stroke
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations