StrokeNCT05128461
The Effectiveness of Telerehabilitation in Stroke Patients
A study testing Exercise and Home program in people with Stroke, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Stroke, according to the definition of the World Health Organization (WHO); It is a syndrome characterized by a rapid settlement of signs and symptoms of focal loss of cerebral function without a cause other than vascular causes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Exercise and Home program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Nov 2021to 20 Oct 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- Being diagnosed with stroke for the first time by a doctor
- Having been diagnosed with stroke at least 1 month ago
- Mini-Mental Test Score more than or equal 24
- In the upper extremities; Starting from the angle of full flexion, wrist extension of at least 20° or more, thumb extension or abduction of at least 10°, minimum extension of all other fingers at the metacarpophalangeal and interphalangeal joints
- Having less than 2.5 points in the pre-treatment evaluation from both parts of MAG-28
Show all 9Show fewer
- Being able to stand for 2 minutes without any help by using the upper extremity as a support tool when necessary.
- Absence of severe pain to affect the treatment
- Absence of severe spasticity to affect the treatment (spasticity in any joint of the upper extremity ≤ 2 according to the Modified Ashworth Scale)
Who cannot join
- Any orthopedic, vision, hearing or perception problems that may affect the research results
- Having an additional neurological, cardiovascular, pulmonary or hormonal disorder that would prevent participation in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Ankara
About this study
Official title: The Effectiveness of Modified-Constraint Induced Movement Therapy Based Telerehabilitation in Stroke Patients
Stroke, according to the definition of the World Health Organization (WHO); It is a syndrome characterized by a rapid settlement of signs and symptoms of focal loss of cerebral function without a cause other than vascular causes. As it is known, it is important for patients to regain functional skills in the upper extremities after stroke. Modified-Constraint Induced Movement Therapy (m-CIMT) is a versatile neurorehabilitation technique that aims to improve motor function in the hemiparetic upper extremity and increase its use in daily life activities. However, as in the Covid-19 pandemic, patients cannot always reach rehabilitation services. In such cases, telerehabilitation is a treatment option. There are a limited number of studies in which m-CIMT is applied according to the principle of telerehabilitation, which has become a necessity, especially due to the Covid-19 pandemic. Therefore, the aim of this study is to examine the effects of m-CIMT on upper extremity motor functions in stroke patients.
Read the detailed description
This study is a randomized controlled study. The patients will be randomly divided into two groups as exercise and control. Patients in both groups will be given lower-upper extremity exercises and gait training exercises selected according to the Bobath approach as a home program consisting of 10 exercises to be applied 5 days a week for 3 weeks. All patients will perform the same exercises. In addition, the exercise group will receive Modified-Constraint Induced Movement Therapy (m-CIMT) based telerehabilitation via video conferencing 5 days a week for 3 weeks. Patients in the m-CIMT group will be asked to restrict the movements of their less affected hands by using mitt for 5 hours a day/ 5 days a week for 3 weeks while the patients are awake. Evaluations for both groups will be made by a physiotherapist blinded to the study twice, at the beginning and 3 weeks later. As outcome measures functional performance, hand strength, activities of daily living and quality of life will be evaluated.
- Conditions
- Stroke
- Being tested
- Exercise, Home program
- Keywords
- Stroke, Telerehabilitation, modified-Constraint Induced Movement Therapy, Upper Extremity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
M-CIMT-based telerehabilitation will be implemented.
Home programOther
Lower and upper extremity exercises and gait training exercises selected according to the Bobath approach will be given as a home program consisting of 10 same exercises.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | The group will receive modified-Constraint Induced Movement Therapy via telerehabilitation and a home exercise program. Receives: Other: Exercise; Other: Home program |
| Control group | Active comparator | The group only will be given a home exercise program. Receives: Other: Home program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity motor ability-Baseline
Wolf Motor Function Test
Measured: Assessment will be conducted before the intervention.
Upper extremity motor ability-Post intervention
Wolf Motor Function Test
Measured: Assessment will be conducted immediately after the intervention.
Upper extremity motor function-Baseline
The Fugl-Meyer Assessment of the Upper Extremity
Measured: Assessment will be conducted before the intervention.
Upper extremity motor function-Post intervention
The Fugl-Meyer Assessment of the Upper Extremity
Measured: Assessment will be conducted immediately after the intervention.
Activities of daily living related to the upper extremity-Baseline
Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better.
Measured: Assessment will be conducted before the intervention.
Activities of daily living related to the upper extremity-Post intervention
Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better.
Measured: Assessment will be conducted immediately after the intervention.
Voluntary movement and mobility-Baseline
Stroke Rehabilitation Assessment of Movement (STREAM)
Measured: Assessment will be conducted before the intervention.
Voluntary movement and mobility-Post intervention
Stroke Rehabilitation Assessment of Movement (STREAM)
Measured: Assessment will be conducted immediately after the intervention.
Secondary outcomes (8)
Isometric hand strength-Baseline
J-Tech™
Measured: Assessment will be conducted before the intervention.
Isometric hand strength-Post intervention
J-Tech™
Measured: Assessment will be conducted immediately after the intervention.
Isometric pinch strength-Baseline
Baseline® pinch meter
Measured: Assessment will be conducted before the intervention.
Isometric pinch strength-Post intervention
Baseline® pinch meter
Measured: Assessment will be conducted immediately after the intervention.
manual dexterity performance-Baseline
nine-hole peg test (9-HTP)
Measured: Assessment will be conducted before the intervention.
manual dexterity performance-Post intervention
nine-hole peg test (9-HTP)
Measured: Assessment will be conducted immediately after the intervention.
level of independence in activities of daily living-Baseline
Functional Independence Measure
Measured: Assessment will be conducted before the intervention.
level of independence in activities of daily living-Post intervention
Functional Independence Measure
Measured: Assessment will be conducted immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start22 Nov 2021
- Primary completion1 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Model description
- Two groups as exercise group and control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fettah Saygılı, Gazi University
- Investigators
- Fettah SAYGILI, PT, M.Sc., Study chair, Research AssistantArzu Güçlü-Gündüz, PT, PhD., Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128461
- Sponsor's protocol ID
- 1-Stroke-CIMT-Telerehab.
- Status last verified
- Jul 2023
- First submitted
- 28 Oct 2021
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD data but when the statistical analysis of all data is made, all results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Modified-Constraint Induced Movement Therapy Based Telerehabilitation in Stroke Patients
- ClinicalTrials.gov ID
- NCT05128461
- Acronym / sponsor ID
- 1-Stroke-CIMT-Telerehab.
- Conditions
- Stroke
- Keywords
- Stroke, Telerehabilitation, modified-Constraint Induced Movement Therapy, Upper Extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 22 Nov 2021 (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.
Stroke, according to the definition of the World Health Organization (WHO); It is a syndrome characterized by a rapid settlement of signs and symptoms of focal loss of cerebral function without a cause other than vascular causes. As it is known, it is important for patients to regain functional skills in the upper extremities after stroke. Modified-Constraint Induced Movement Therapy (m-CIMT) is a versatile neurorehabilitation technique that aims to improve motor function in the hemiparetic upper extremity and increase its use in daily life activities. However, as in the Covid-19 pandemic, patients cannot always reach rehabilitation services. In such cases, telerehabilitation is a treatment option. There are a limited number of studies in which m-CIMT is applied according to the principle of telerehabilitation, which has become a necessity, especially due to the Covid-19 pandemic. Therefore, the aim of this study is to examine the effects of m-CIMT on upper extremity motor functions in stroke patients.
Detailed description
This study is a randomized controlled study. The patients will be randomly divided into two groups as exercise and control. Patients in both groups will be given lower-upper extremity exercises and gait training exercises selected according to the Bobath approach as a home program consisting of 10 exercises to be applied 5 days a week for 3 weeks. All patients will perform the same exercises. In addition, the exercise group will receive Modified-Constraint Induced Movement Therapy (m-CIMT) based telerehabilitation via video conferencing 5 days a week for 3 weeks. Patients in the m-CIMT group will be asked to restrict the movements of their less affected hands by using mitt for 5 hours a day/ 5 days a week for 3 weeks while the patients are awake. Evaluations for both groups will be made by a physiotherapist blinded to the study twice, at the beginning and 3 weeks later. As outcome measures functional performance, hand strength, activities of daily living and quality of life will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups as exercise group and control group
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Exercise, Other: Home programThe group will receive modified-Constraint Induced Movement Therapy via telerehabilitation and a home exercise program. |
| Control group | Active comparator | Other: Home programThe group only will be given a home exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18-65 years of age
- Being diagnosed with stroke for the first time by a doctor
- Having been diagnosed with stroke at least 1 month ago
- Mini-Mental Test Score more than or equal 24
- In the upper extremities; Starting from the angle of full flexion, wrist extension of at least 20° or more, thumb extension or abduction of at least 10°, minimum extension of all other fingers at the metacarpophalangeal and interphalangeal joints
Key exclusion criteria (2 listed)
- Any orthopedic, vision, hearing or perception problems that may affect the research results
- Having an additional neurological, cardiovascular, pulmonary or hormonal disorder that would prevent participation in the study.
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 |
|---|---|---|
| ExerciseM-CIMT-based telerehabilitation will be implemented. | Other | Exercise Group |
| Home programLower and upper extremity exercises and gait training exercises selected according to the Bobath approach will be given as a home program consisting of 10 same exercises. | Other | Control group, Exercise Group |
Primary outcome
Upper extremity motor ability-Baseline
Time frame: Assessment will be conducted before the intervention.
Wolf Motor Function Test
Upper extremity motor ability-Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Wolf Motor Function Test
Upper extremity motor function-Baseline
Time frame: Assessment will be conducted before the intervention.
The Fugl-Meyer Assessment of the Upper Extremity
Upper extremity motor function-Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
The Fugl-Meyer Assessment of the Upper Extremity
Activities of daily living related to the upper extremity-Baseline
Time frame: Assessment will be conducted before the intervention.
Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better.
Activities of daily living related to the upper extremity-Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better.
Voluntary movement and mobility-Baseline
Time frame: Assessment will be conducted before the intervention.
Stroke Rehabilitation Assessment of Movement (STREAM)
Voluntary movement and mobility-Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Stroke Rehabilitation Assessment of Movement (STREAM)
8 secondary outcomes
Isometric hand strength-Baseline
Time frame: Assessment will be conducted before the intervention.
Isometric hand strength-Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
Isometric pinch strength-Baseline
Time frame: Assessment will be conducted before the intervention.
Isometric pinch strength-Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
manual dexterity performance-Baseline
Time frame: Assessment will be conducted before the intervention.
manual dexterity performance-Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
level of independence in activities of daily living-Baseline
Time frame: Assessment will be conducted before the intervention.
level of independence in activities of daily living-Post intervention
Time frame: Assessment will be conducted immediately after the intervention.
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 11 Jul 2023.
- Related infoLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make IPD data but when the statistical analysis of all data is made, all results will be shared.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Fettah SAYGILI, PT, M.Sc. study chair
Research Assistant
Arzu Güçlü-Gündüz, PT, PhD. study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Home program in people with Stroke, run by Gazi 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 9 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 11 Jul 2023. 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 motor ability-Baseline (time frame: Assessment will be conducted before the intervention.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2023.