Stroke RehabilitationNCT03834311
The Effectiveness of Upper Extremity Isokinetic Strengthening in Post-stroke Hemiplegia
A study testing isokinetic strengthening and exercise band strengthening in people with Stroke Rehabilitation and Hemiplegia, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This randomised controlled study will investigate the effectiveness of isokinetic strengthening on the upper extremity functionality and strength in post-stroke hemiplegic patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke Rehabilitation, Hemiplegia
- What is being tested?
- isokinetic strengthening and exercise band strengthening
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Feb 2019to 15 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active motion in upper extremity
- Brunnstrom's Scale above 3
Who cannot join
- Unstable medical conditions
- Cognitive problems
Trial locations and contacts
1 site in 1 country.
About this study
This randomised controlled study will investigate the effectiveness of isokinetic strengthening on the upper extremity functionality and strength in post-stroke hemiplegic patients.
- Conditions
- Stroke Rehabilitation, Hemiplegia
- Being tested
- isokinetic strengthening, exercise band strengthening
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isokinetic strengtheningDevice
isokinetic upper extremity (forearm) strengthening for 4 weeks 3d/w
exercise band strengtheningOther
upper extremity (forearm) strengthening with exercise band 4 weeks 3d/w
| Study group | Role | What they receive |
|---|---|---|
| isokinetic | Experimental | Not described Receives: Device: isokinetic strengthening |
| exercise band | Active comparator | Not described Receives: Other: exercise band strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper extremity strength
Muscles: forearm flexors and extensors Measurement tool: MicroFET3 (Hoggan Health Industries Inc. West Jordan, UT, USA)
Measured: 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)
Measured: 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
Measurement tool: Jamar Hydraulic Hand Dynamometer (Patterson Medical, Warrenville, IL, USA)
Measured: 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
Measured: 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
Measured: 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.
Measured: 0, 4, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start21 Feb 2019
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke RehabilitationStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilke Coskun Benlidayi, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834311
- Sponsor's protocol ID
- CukurovaPMR
- Status last verified
- Jan 2020
- First submitted
- 6 Jan 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 33765633
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Upper Extremity Isokinetic Strengthening in Post-stroke Hemiplegia
- ClinicalTrials.gov ID
- NCT03834311
- Acronym / sponsor ID
- CukurovaPMR
- Conditions
- Stroke Rehabilitation, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomised controlled study will investigate the effectiveness of isokinetic strengthening on the upper extremity functionality and strength in post-stroke hemiplegic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isokinetic | Experimental | Device: isokinetic strengthening |
| exercise band | Active comparator | Other: exercise band strengthening |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Active motion in upper extremity
- Brunnstrom's Scale above 3
Key exclusion criteria (2 listed)
- Unstable medical conditions
- Cognitive problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isokinetic strengtheningisokinetic upper extremity (forearm) strengthening for 4 weeks 3d/w | Device | isokinetic |
| exercise band strengtheningupper extremity (forearm) strengthening with exercise band 4 weeks 3d/w | Other | exercise band |
Primary outcome
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)
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)
4 secondary outcomes
hand grip strength
Time frame: 0, 4, 8 weeks
Fugl-Meyer Assessment scale for upper extremity
Time frame: 0, 4, 8 weeks
Disabilities of the arm, shoulder and hand questionnaire (Part 1)
Time frame: 0, 4, 8 weeks
Stroke Impact Scale version 3.0
Time frame: 0, 4, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 33765633Kerimov 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isokinetic strengthening and exercise band strengthening in people with Stroke Rehabilitation and Hemiplegia, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03834311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.