NCT03834311

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

February 21, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

January 6, 2019

Last Update Submit

January 24, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • hand grip strength

    0, 4, 8 weeks

  • Fugl-Meyer Assessment scale for upper extremity

    0, 4, 8 weeks

  • Disabilities of the arm, shoulder and hand questionnaire (Part 1)

    0, 4, 8 weeks

  • Stroke Impact Scale version 3.0

    0, 4, 8 weeks

Study Arms (2)

isokinetic

EXPERIMENTAL
Device: isokinetic strengthening

exercise band

ACTIVE COMPARATOR
Other: exercise band strengthening

Interventions

isokinetic upper extremity (forearm) strengthening for 4 weeks 3d/w

isokinetic

upper extremity (forearm) strengthening with exercise band 4 weeks 3d/w

exercise band

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unstable medical conditions
  • Cognitive problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İlke COŞKUN BENLİDAYI

Adana, 01330, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 6, 2019

First Posted

February 7, 2019

Study Start

February 21, 2019

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations