HemiplegiaNCT06542848
Impact of Physiotherapy on Spasticity, Upper Limb Function, Daily Activities, and Kinesiophobia in Hemiplegic Patients
A study testing Physiotherapy and Rehabilitation Practices in people with Hemiplegia and Stroke, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
This study investigated the effects of rehabilitation exercises on spasticity levels, upper extremity functions, activities of daily living, and kinesiophobia in patients with hemiplegia following a stroke. Read more about this study
- Who is it for?
- Ages 22 to 79 years
- Conditions the study is for
- Hemiplegia, Stroke
- What is being tested?
- Physiotherapy and Rehabilitation Practices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 15 Jul 2024
- 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 22 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between 22-79 years of age
- Having been diagnosed with a stroke (SVO)
- Possessing adequate language and cognitive skills
- Willingness to participate voluntarily
- Not having any chronic diseases that could affect the study outcomes
Who cannot join
- No other neurological problems affecting functionality besides hemiplegia
- Having cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Physiotherapy Rehabilitation Program on Spasticity Level, Upper Extremity Functions, Activities of Daily Living, and Kinesiophobia in Hemiplegic Patients
This study investigated the effects of rehabilitation exercises on spasticity levels, upper extremity functions, activities of daily living, and kinesiophobia in patients with hemiplegia following a stroke.
Read the detailed description
Hemiplegia is a neurological condition characterized by paresis and movement limitations on one side of the body due to functional loss in one hemisphere of the brain caused by a vascular event after a stroke. This study aims to evaluate the effects of a physiotherapy and rehabilitation program on spasticity levels, upper extremity functions, activities of daily living, and kinesiophobia in patients with post-stroke hemiplegia.
Participants' spasticity levels were assessed using the Modified Ashworth Scale, upper extremity functions with the Fugl-Meyer Upper Extremity Motor Assessment, activities of daily living with the Barthel Index, and kinesiophobia levels with the Tampa Scale of Kinesiophobia. The treatment program consisted of 24 sessions, with three sessions per week. Each session lasted 45 minutes and included Transcutaneous Electrical Nerve Stimulation (TENS), range of motion exercises for upper and lower extremities, balance and coordination exercises, and weight transfer exercises. Assessments were conducted before and after the treatment.
As a result of the treatment program, a significant decrease in spasticity levels was observed in joints other than the hip joint, along with significant improvements in upper extremity functions and activities of daily living, and a significant reduction in kinesiophobia levels.
Physiotherapy and rehabilitation programs have been found to be effective in reducing spasticity, improving upper extremity functions and activities of daily living, and reducing kinesiophobia in post-stroke hemiplegic patients. These findings can contribute to the development of post-stroke rehabilitation strategies. Future research should deepen these findings with larger sample groups and long-term follow-up studies.
- Conditions
- Hemiplegia, Stroke
- Being tested
- Physiotherapy and Rehabilitation Practices
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy and Rehabilitation PracticesOther
The treatment program consisted of 3 sessions per week, each lasting 45 minutes. The rehabilitation program included 30 minutes of conventional TENS application to the wrist extensor muscles and quadriceps muscle, upper and lower extremity exercises, balance and coordination exercises, and weight transfer exercises. The upper extremity exercises consisted of range of motion exercises for the shoulder joint, while the lower extremity exercises included range of motion exercises for the hip, knee, and ankle joints. Balance exercises included forward, backward, and lateral leaning exercises, as well as weight transfer and stepping exercises in all directions. The treatment duration was planned to be a total of 24 sessions over 8 weeks. Evaluations were conducted before and after the treatment program.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | This group consists of patients with post-stroke hemiplegia who will undergo a physiotherapy and rehabilitation program to assess its effects on spasticity levels, upper extremity functions, activities of daily living, and kinesiophobia. Receives: Other: Physiotherapy and Rehabilitation Practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Rehabilitation Program on Spasticity with Modified Ashworth Scale
The primary outcome measure evaluates the changes in spasticity levels. The Modified Ashworth Scale is a measurement system based on manually assessing the resistance of specific muscle groups to passive movement. This scale evaluates the resistance encountered during passive movement of the extremity, scoring it from 0 to 4. As the score increases, it indicates a higher level of spasticity.
Measured: Baseline (pre-treatment) and 8 weeks (post-treatment)
Effect of Rehabilitation Program on Upper Extremity Motor Function with Fugl-Meyer Assessment of Upper Extremity Motor Function
The Fugl-Meyer Assessment of Upper Extremity Motor Function is a disease-specific, objective motor impairment scale designed to evaluate recovery in hemiplegic patients following a stroke. The highest possible score on this assessment is 66. An increase in the score indicates better motor skills.
Measured: Baseline (pre-treatment) and 8 weeks (post-treatment)
Effect of Rehabilitation Program on Daily Living Activities with Barthel Index of Activities of Daily Living
The Barthel Index of Activities of Daily Living consists of 10 items related to daily activities and mobility. The highest possible total score is 100, indicating that the individual is completely independent in their physical functions. The lowest score is 0, indicating that the individual is entirely dependent.
Measured: Baseline (pre-treatment) and 8 weeks (post-treatment)
Effect of Rehabilitation Program on Kinesiophobia with Tampa Scale for Kinesiophobia
The Tampa Scale for Kinesiophobia is a self-report measure developed to assess fear of movement. It consists of 17 items. A high score indicates a high level of fear of movement, while a low score indicates a negligible level of fear of movement. The total score, obtained by summing the individual items, ranges from 17 to 68.
Measured: Baseline (pre-treatment) and 8 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 May 2024
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Şahbaz, University of Beykent
- Investigators
- Yasemin ŞAHBAZ, PhD, Principal investigator, Beykent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542848
- Sponsor's protocol ID
- UBeykent-7
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physiotherapy Rehabilitation Program on Spasticity Level, Upper Extremity Functions, Activities of Daily Living, and Kinesiophobia in Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT06542848
- Acronym / sponsor ID
- UBeykent-7
- Conditions
- Hemiplegia, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 7 Aug 2024 (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 investigated the effects of rehabilitation exercises on spasticity levels, upper extremity functions, activities of daily living, and kinesiophobia in patients with hemiplegia following a stroke.
Detailed description
Hemiplegia is a neurological condition characterized by paresis and movement limitations on one side of the body due to functional loss in one hemisphere of the brain caused by a vascular event after a stroke. This study aims to evaluate the effects of a physiotherapy and rehabilitation program on spasticity levels, upper extremity functions, activities of daily living, and kinesiophobia in patients with post-stroke hemiplegia.
Participants' spasticity levels were assessed using the Modified Ashworth Scale, upper extremity functions with the Fugl-Meyer Upper Extremity Motor Assessment, activities of daily living with the Barthel Index, and kinesiophobia levels with the Tampa Scale of Kinesiophobia. The treatment program consisted of 24 sessions, with three sessions per week. Each session lasted 45 minutes and included Transcutaneous Electrical Nerve Stimulation (TENS), range of motion exercises for upper and lower extremities, balance and coordination exercises, and weight transfer exercises. Assessments were conducted before and after the treatment.
As a result of the treatment program, a significant decrease in spasticity levels was observed in joints other than the hip joint, along with significant improvements in upper extremity functions and activities of daily living, and a significant reduction in kinesiophobia levels.
Physiotherapy and rehabilitation programs have been found to be effective in reducing spasticity, improving upper extremity functions and activities of daily living, and reducing kinesiophobia in post-stroke hemiplegic patients. These findings can contribute to the development of post-stroke rehabilitation strategies. Future research should deepen these findings with larger sample groups and long-term follow-up studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Physiotherapy and Rehabilitation PracticesThis group consists of patients with post-stroke hemiplegia who will undergo a physiotherapy and rehabilitation program to assess its effects on spasticity levels, upper extremity functions, activities of daily living, and kinesiophobia. |
Who may qualify
- Ages
- 22 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being between 22-79 years of age
- Having been diagnosed with a stroke (SVO)
- Possessing adequate language and cognitive skills
- Willingness to participate voluntarily
- Not having any chronic diseases that could affect the study outcomes
Key exclusion criteria (2 listed)
- No other neurological problems affecting functionality besides hemiplegia
- Having cognitive impairment
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 |
|---|---|---|
| Physiotherapy and Rehabilitation PracticesThe treatment program consisted of 3 sessions per week, each lasting 45 minutes. The rehabilitation program included 30 minutes of conventional TENS application to the wrist extensor muscles and quadriceps muscle, upper and lower extremity exercises, balance and coordination exercises, and weight transfer exercises. The upper extremity exercises consisted of range of motion exercises for the shoulder joint, while the lower extremity exercises included range of motion exercises for the hip, knee, and ankle joints. Balance exercises included forward, backward, and lateral leaning exercises, as well as weight transfer and stepping exercises in all directions. The treatment duration was planned to be a total of 24 sessions over 8 weeks. Evaluations were conducted before and after the treatment program. | Other | Experimental Group |
Primary outcome
Effect of Rehabilitation Program on Spasticity with Modified Ashworth Scale
Time frame: Baseline (pre-treatment) and 8 weeks (post-treatment)
The primary outcome measure evaluates the changes in spasticity levels. The Modified Ashworth Scale is a measurement system based on manually assessing the resistance of specific muscle groups to passive movement. This scale evaluates the resistance encountered during passive movement of the extremity, scoring it from 0 to 4. As the score increases, it indicates a higher level of spasticity.
Effect of Rehabilitation Program on Upper Extremity Motor Function with Fugl-Meyer Assessment of Upper Extremity Motor Function
Time frame: Baseline (pre-treatment) and 8 weeks (post-treatment)
The Fugl-Meyer Assessment of Upper Extremity Motor Function is a disease-specific, objective motor impairment scale designed to evaluate recovery in hemiplegic patients following a stroke. The highest possible score on this assessment is 66. An increase in the score indicates better motor skills.
Effect of Rehabilitation Program on Daily Living Activities with Barthel Index of Activities of Daily Living
Time frame: Baseline (pre-treatment) and 8 weeks (post-treatment)
The Barthel Index of Activities of Daily Living consists of 10 items related to daily activities and mobility. The highest possible total score is 100, indicating that the individual is completely independent in their physical functions. The lowest score is 0, indicating that the individual is entirely dependent.
Effect of Rehabilitation Program on Kinesiophobia with Tampa Scale for Kinesiophobia
Time frame: Baseline (pre-treatment) and 8 weeks (post-treatment)
The Tampa Scale for Kinesiophobia is a self-report measure developed to assess fear of movement. It consists of 17 items. A high score indicates a high level of fear of movement, while a low score indicates a negligible level of fear of movement. The total score, obtained by summing the individual items, ranges from 17 to 68.
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 7 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Hemiplegia
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Functional Benefits of Multisite Upper Limb Surgery in Children With Unilateral Cerebral Palsy (RETRO-CHIRc)
Cerebral Palsy, Hemiplegia
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Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
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Post-Stroke Apraxia, Motor Function, Balance, and Gait
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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.
Yasemin ŞAHBAZ, PhD principal investigator
Beykent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy and Rehabilitation Practices in people with Hemiplegia and Stroke, run by University of Beykent 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 5 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 7 Aug 2024. 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?
Effect of Rehabilitation Program on Spasticity with Modified Ashworth Scale (time frame: Baseline (pre-treatment) and 8 weeks (post-treatment)). The study lists 4 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 7 Aug 2024.