StrokeNCT07915141
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
A study testing Supervised Upper Extremity Physiotherapy Program and Home Exercise Program in people with Stroke, run by Istanbul Gelisim University at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of an upper extremity physiotherapy program combined with home exercises on activities of daily living, quality of life, joint range of motion, and pain in individuals with hemiplegia following stroke. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Supervised Upper Extremity Physiotherapy Program and Home Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Nov 2026to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stroke.
- Age greater than 30 and less than 65 years.
- Time since stroke between 1 and 5 years.
- Voluntary participation in the study and treatment.
- Upper extremity Brunnstrom recovery stage 2 or 3.
- Ability to understand and perform the prescribed exercise program.
Who cannot join
- Unwillingness to continue participation in the study or treatment.
- Irregular attendance at scheduled treatment sessions.
- Upper extremity contracture severe enough to prevent exercise performance or range of motion assessment.
- Spasticity severe enough to prevent safe and effective upper extremity exercise performance.
- Failure to perform the prescribed home exercises regularly.
- Development of an additional disease or medical condition affecting upper extremity function during the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Avrasya Hospital Gaziosmanpaşa and zeytinburnu
Istanbul
ali emre takkin, MsC, +90 507 154 48 87, aliemre.takkin@gmail.com
Gülşen Yıldız, BSc
Avrasya Hospital- Gaziosmanpaşa and Zeytinburnu
Istanbul
Ali Emre Takkin, MsC, +90 507 154 48 87, aliemre.takkin@gmail.com
Gülşen Yıldız, Bsc
About this study
Official title: The Effect of a Physiotherapy Program Developed for the Upper Extremity in Hemiplegic İndividuals on Daily Living aAtivities and Quality of Life.
This study aims to investigate the effects of an upper extremity physiotherapy program combined with home exercises on activities of daily living, quality of life, joint range of motion, and pain in individuals with hemiplegia following stroke.
The study compares two groups: participants receiving supervised physiotherapy in addition to a home exercise program and participants performing a home exercise program only. The intervention includes stretching, range-of-motion exercises, arm ergometer training, progressive strengthening, coordination exercises, and fine motor activities.
Read more
The intervention period lasts 10 weeks. Outcomes are assessed using the Barthel Index, Short Form-36 (SF-36), Visual Analog Scale (VAS), goniometric measurements, and sensory assessments.
The study aims to evaluate whether adding supervised physiotherapy to home exercises provides additional benefits for upper extremity rehabilitation following stroke.
- Conditions
- Stroke
- Being tested
- Supervised Upper Extremity Physiotherapy Program, Home Exercise Program
- Keywords
- Hemiplegia, Upper Extremity Rehabilitation, Physiotherapy, Home Exercise Program, Activities of Daily Living, Quality of Life
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Upper Extremity Physiotherapy ProgramBehavioural
Participants in the intervention group receive a 10-week rehabilitation program consisting of supervised upper extremity physiotherapy twice weekly for 45 minutes per session and a structured home exercise program on three non-treatment days per week. The home exercise program is identical in content to that of the control group and includes upper extremity range-of-motion exercises, stretching, wall exercises, light resistance exercises using towels, Theraband and water bottles, hand-eye coordination training, and fine motor activities. Home exercises are performed twice daily for 30 minutes per session, with 10 repetitions of each exercise. Supervised physiotherapy includes stretching, passive, active-assisted and active range-of-motion exercises, wand exercises, arm ergometer training, progressive strengthening using Theraband and 0.5 kg dumbbells, coordination exercises, and fine motor activities.
Home Exercise ProgramBehavioural
Participants in the control group perform a structured home exercise program five days per week for 10 weeks. The program includes upper extremity range-of-motion exercises, stretching, wall exercises, light resistance exercises using towels, Theraband and water bottles, hand-eye coordination exercises, and fine motor activities. The exercises are performed twice daily for 30 minutes per session, with 10 repetitions of each exercise. The content of the home exercise program is the same as that prescribed to the intervention group. No supervised physiotherapy sessions are provided to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy and Home Exercise Group | Experimental | Participants in this group receive supervised upper extremity physiotherapy twice a week for 45 minutes over 10 weeks, in addition to a home exercise program. The physiotherapy program includes stretching, passive and active-assisted range-of-motion exercises, arm ergometer training, progressive resistance exercises using Theraband and dumbbells, coordination exercises, and fine motor activities. The home exercise program is performed five days per week, twice daily for 30 minutes per session. Receives: Behavioral: Supervised Upper Extremity Physiotherapy Program; Behavioral: Home Exercise Program |
| Home Exercise Group | Active comparator | physiotherapy sessions. The program includes upper extremity range-of-motion exercises, stretching, wall exercises, light resistance exercises using towels, Theraband and water bottles, hand-eye coordination exercises, and fine motor activities. Exercises are performed five days per week, twice daily for 30 minutes per session, with 10 repetitions of each exercise. Receives: Behavioral: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Barthel Index Score
The Barthel Index is used to assess independence in activities of daily living. Total scores range from 0 to 100, with higher scores indicating greater functional independence. Changes in Barthel Index scores from baseline to the end of the 10-week intervention are compared between the intervention and control groups.
Measured: Baseline (Week 1) and post-intervention (Week 10)
Change in SF-36 Quality of Life Scores
The SF-36 is used to assess health-related quality of life across eight domains. Scores for each domain range from 0 to 100, with higher scores indicating better health-related quality of life. Changes in scores from baseline to the end of the 10-week intervention are compared between the two groups.
Measured: Baseline (Week 1) and post-intervention (Week 10)
Secondary outcomes (3)
Change in Upper Extremity Range of Motion (ROM)
Upper extremity range of motion is assessed using a goniometer. Measurements include shoulder flexion, extension and abduction; elbow flexion and extension; and wrist flexion and extension. Range of motion is recorded in degrees (°), with higher values indicating greater joint mobility. Changes from baseline to Week 10 are compared between the two groups.
Measured: Baseline (Week 1) and post-intervention (Week 10)
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Pain intensity is assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Changes in VAS scores from baseline to the end of the 10-week intervention are compared between the intervention and control groups.
Measured: Baseline (Week 1) and post-intervention (Week 10)
Change in Upper Extremity Sensory Function
Upper extremity sensory function is assessed using superficial, deep, and cortical sensory tests, including temperature discrimination, sharp-dull discrimination, joint position sense (proprioception), and stereognosis. Changes in sensory function from baseline to Week 10 are evaluated in both groups.
Measured: Baseline (Week 1) and post-intervention (Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completion11 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a non-randomized, controlled, parallel-group design. Participants are assigned to two groups: an intervention group receiving supervised upper extremity physiotherapy combined with home exercises and a control group receiving home exercises only. Both groups follow a 10-week intervention program.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hande B Besna Göçen, PhD, Study chair, Istanbul Gelisim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915141
- Sponsor's protocol ID
- STROKE-UE-2025-01
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Physiotherapy Program Developed for the Upper Extremity in Hemiplegic İndividuals on Daily Living aAtivities and Quality of Life.
- ClinicalTrials.gov ID
- NCT07915141
- Acronym / sponsor ID
- STROKE-UE-2025-01
- Conditions
- Stroke
- Keywords
- Hemiplegia, Upper Extremity Rehabilitation, Physiotherapy, Home Exercise Program, Activities of Daily Living, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 11 Jan 2027 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 4 Nov 2026 (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 study aims to investigate the effects of an upper extremity physiotherapy program combined with home exercises on activities of daily living, quality of life, joint range of motion, and pain in individuals with hemiplegia following stroke.
The study compares two groups: participants receiving supervised physiotherapy in addition to a home exercise program and participants performing a home exercise program only. The intervention includes stretching, range-of-motion exercises, arm ergometer training, progressive strengthening, coordination exercises, and fine motor activities.
The intervention period lasts 10 weeks. Outcomes are assessed using the Barthel Index, Short Form-36 (SF-36), Visual Analog Scale (VAS), goniometric measurements, and sensory assessments.
The study aims to evaluate whether adding supervised physiotherapy to home exercises provides additional benefits for upper extremity rehabilitation following stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a non-randomized, controlled, parallel-group design. Participants are assigned to two groups: an intervention group receiving supervised upper extremity physiotherapy combined with home exercises and a control group receiving home exercises only. Both groups follow a 10-week intervention program.
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy and Home Exercise Group | Experimental | Behavioral: Supervised Upper Extremity Physiotherapy Program, Behavioral: Home Exercise ProgramParticipants in this group receive supervised upper extremity physiotherapy twice a week for 45 minutes over 10 weeks, in addition to a home exercise program. The physiotherapy program includes stretching, passive and active-assisted range-of-motion exercises, arm ergometer training, progressive resistance exercises using Theraband and dumbbells, coordination exercises, and fine motor activities. The home exercise program is performed five days per week, twice daily for 30 minutes per session. |
| Home Exercise Group | Active comparator | Behavioral: Home Exercise Programphysiotherapy sessions. The program includes upper extremity range-of-motion exercises, stretching, wall exercises, light resistance exercises using towels, Theraband and water bottles, hand-eye coordination exercises, and fine motor activities. Exercises are performed five days per week, twice daily for 30 minutes per session, with 10 repetitions of each exercise. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of stroke.
- Age greater than 30 and less than 65 years.
- Time since stroke between 1 and 5 years.
- Voluntary participation in the study and treatment.
- Upper extremity Brunnstrom recovery stage 2 or 3.
Key exclusion criteria (6 listed)
- Unwillingness to continue participation in the study or treatment.
- Irregular attendance at scheduled treatment sessions.
- Upper extremity contracture severe enough to prevent exercise performance or range of motion assessment.
- Spasticity severe enough to prevent safe and effective upper extremity exercise performance.
- Failure to perform the prescribed home exercises regularly.
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 |
|---|---|---|
| Supervised Upper Extremity Physiotherapy ProgramParticipants in the intervention group receive a 10-week rehabilitation program consisting of supervised upper extremity physiotherapy twice weekly for 45 minutes per session and a structured home exercise program on three non-treatment days per week. The home exercise program is identical in content to that of the control group and includes upper extremity range-of-motion exercises, stretching, wall exercises, light resistance exercises using towels, Theraband and water bottles, hand-eye coordination training, and fine motor activities. Home exercises are performed twice daily for 30 minutes per session, with 10 repetitions of each exercise. Supervised physiotherapy includes stretching, passive, active-assisted and active range-of-motion exercises, wand exercises, arm ergometer training, progressive strengthening using Theraband and 0.5 kg dumbbells, coordination exercises, and fine motor activities. | Behavioural | Physiotherapy and Home Exercise Group |
| Home Exercise ProgramParticipants in the control group perform a structured home exercise program five days per week for 10 weeks. The program includes upper extremity range-of-motion exercises, stretching, wall exercises, light resistance exercises using towels, Theraband and water bottles, hand-eye coordination exercises, and fine motor activities. The exercises are performed twice daily for 30 minutes per session, with 10 repetitions of each exercise. The content of the home exercise program is the same as that prescribed to the intervention group. No supervised physiotherapy sessions are provided to the control group. | Behavioural | Home Exercise Group, Physiotherapy and Home Exercise Group |
Primary outcome
Change in Barthel Index Score
Time frame: Baseline (Week 1) and post-intervention (Week 10)
The Barthel Index is used to assess independence in activities of daily living. Total scores range from 0 to 100, with higher scores indicating greater functional independence. Changes in Barthel Index scores from baseline to the end of the 10-week intervention are compared between the intervention and control groups.
Change in SF-36 Quality of Life Scores
Time frame: Baseline (Week 1) and post-intervention (Week 10)
The SF-36 is used to assess health-related quality of life across eight domains. Scores for each domain range from 0 to 100, with higher scores indicating better health-related quality of life. Changes in scores from baseline to the end of the 10-week intervention are compared between the two groups.
3 secondary outcomes
Change in Upper Extremity Range of Motion (ROM)
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Change in Upper Extremity Sensory Function
Time frame: Baseline (Week 1) and post-intervention (Week 10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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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.
Hande B Besna Göçen, PhD study chair
Istanbul Gelisim University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Upper Extremity Physiotherapy Program and Home Exercise Program in people with Stroke, run by Istanbul Gelisim University at 2 sites 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gülşen Yıldız, Bachelor of Science - Lisans (+90 551 220 29 09, gulsen.997178@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Barthel Index Score (time frame: Baseline (Week 1) and post-intervention (Week 10)). 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?
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 4 Nov 2026.