Hemiparesis After StrokeNCT07254273
Boccia Exercises and Upper Limb Muscle Adaptations in Hemiparetic Individuals
A study testing Boccia exercise and physiotherapy in people with Hemiparesis After Stroke, run by Bayburt University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates whether adding Boccia exercises to conventional rehabilitation improves upper extremity muscle thickness and grip strength in individuals with hemiparesis following stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemiparesis After Stroke
- What is being tested?
- Boccia exercise and physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2024to 20 Jan 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-75
- Having had a stroke within the last 6-24 months and diagnosed with hemiparesis
- Mild to moderate motor function loss in the upper extremity (e.g., Fugl-Meyer Upper Extremity Score ≥ 20/66)
- Clinically stable individuals eligible to participate in sessions
- Be conscious, cognitively able to follow instructions, and consent
- Be physically fit enough to participate in exercise at least 3 days a week
Who cannot join
- Limited upper extremity movement due to severe spasticity, contracture, or joint deformity (Modified Ashworth Scale ≥ 3)
- Contraindication to exercise due to severe cardiovascular, pulmonary, or systemic disease
- Serious diseases other than neurological disorders (e.g., Parkinson's, MS, tumor)
- History of upper extremity surgery or trauma within the last 6 months
- Inability to exercise due to severe pain, infection, or skin lesions
- Inability to follow instructions due to psychiatric or cognitive impairment
- Concurrent participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Boccia Exercises on Upper Extremity Muscle Thickness and Grip Strength in Hemiparetic Individuals: A Randomized Controlled Trial
This study investigates whether adding Boccia exercises to conventional rehabilitation improves upper extremity muscle thickness and grip strength in individuals with hemiparesis following stroke. The research aims to determine if Boccia training can enhance muscle morphology and functional strength beyond standard physical therapy.
Read the detailed description
Loss of upper extremity function after stroke significantly reduces independence in daily living. Changes in muscle morphology (muscle thickness, echogenicity, pennation, etc.) can affect strength, coordination, and functional performance. Boccia is a sport originally designed for individuals with special needs, encouraging hand-eye coordination, targeting, and force-controlled repetitions. Due to these characteristics, it has been suggested that boccia may positively impact both motor control and muscle tone; however, its effects on muscle morphology and grip strength in hemiparetic individuals have been limitedly studied. This study will investigate the contribution of boccia exercises to conventional physiotherapy on upper extremity muscle thickness and grip strength.
Primary objective: To evaluate whether boccia exercises provide significant improvements in upper extremity muscle thickness and grip strength after hemiparesis, in addition to conventional physical therapy.
Hypothesis: Participants who receive up to nine weeks of extended or eight weeks (8 weeks in the protocol) of boccia practice will show greater improvements in upper extremity muscle thickness and grip strength than those who receive conventional physical therapy alone.
This study is a parallel-group, random assignment controlled trial. The total sample included 22 stroke (hemiparetic) individuals; participants were randomly assigned to two groups: Boccia + physical therapy (Boc, n = 12) and physical therapy alone (Ctrl, n = 10). Assessments will be conducted at pre-intervention (baseline) and post-intervention (after 8 weeks). Assessors will be blinded to the measurements; complete blinding of operators and participants is not possible.
- Conditions
- Hemiparesis After Stroke
- Being tested
- Boccia exercise, physiotherapy
- Keywords
- Stroke, ultrasound, upper extremity, hemiparatic, muscle thickness
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boccia exerciseOther
Boccia exercises differ significantly from other rehabilitation interventions for individuals with physical disabilities. Traditional physical therapy or exercise programs often involve repetitive, motivating movements that lack motivation and cannot be directly linked to individuals' daily activities. However, thanks to its game-based structure, Boccia offers a fun and functional exercise platform. This increases individuals' motivation to participate, facilitates continuity, and brings a more natural setting to the rehabilitation process. Furthermore, Boccia supports the active use of upper extremity muscles and the development of balance and coordination, while also encouraging social interaction and a sense of competition. Therefore, Boccia's game-based and accessible structure offers a more applicable and sustainable approach to developing motor skills and increasing functional independence in individuals with physical disabilities compared to other traditional interventions.
physiotherapyOther
Conventional physical therapy (physiotherapy) is a proven rehabilitation approach aimed at improving upper extremity function, muscle strength, and range of motion in hemiparetic individuals who have had a stroke. The program includes strengthening exercises, joint mobilization, task-oriented functional activities, and motor relearning techniques. Sessions are individualized and tailored to the participant's clinical condition to increase independent participation in activities of daily living in hemiparetic individuals. Regular and structured practice helps prevent the development of muscle atrophy and contractures and maximize functional gains.
| Study group | Role | What they receive |
|---|---|---|
| Boccia Exercise Group | Experimental | Participants in this group will receive conventional physical therapy combined with Boccia exercises three times per week for 8 weeks. Each session lasts approximately 45-60 minutes and includes warm-up, Boccia skill drills (target aiming, throwing control), and cool-down activities. Receives: Other: Boccia exercise; Other: physiotherapy |
| Control Group | Active comparator | Participants in this group will receive only conventional physical therapy three times per week for 8 weeks. The program includes strengthening, range of motion, and task-specific functional exercises matched in duration and frequency to the experimental group. Receives: Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper extremity muscle thickness
Muscle thickness of selected upper extremity muscles (e.g., biceps brachii, triceps brachii, deltoid) is measured using ultrasonography. Measurements are taken at standard anatomic locations with the participant in a relaxed, resting position. Thickness is recorded in millimeters (mm) and represents the distance between the superficial and deep aponeuroses of the muscle. Assessments are performed before (baseline) and after (8 weeks) the intervention by blinded assessors to assess changes in muscle morphology.
Measured: 8 weeks
Secondary outcomes (1)
Grip Strength
Maximum voluntary grip strength of the affected hand is measured using a hand dynamometer. Participants are seated with the elbow flexed at 90° and the forearm in neutral position. Three trials are performed, with brief rest periods between attempts, and the highest value (in kilograms, kg) is recorded. Assessments are conducted pre-intervention (baseline) and post-intervention (after 8 weeks) by blinded assessors to evaluate changes in upper extremity functional strength.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start24 Oct 2024
- Primary completion1 Nov 2024
- Study completion20 Jan 2025
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 Hemiparesis After 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional Study Model: Design: Randomized Controlled, Parallel Assignment, Pretest-Posttest Design Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment / Rehabilitation
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayburt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Berk HAZAR, Bayburt University
- Investigators
- EMRE B HAZAR, Master Degree, Principal investigator, Bayburt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254273
- Sponsor's protocol ID
- E-15604681-100-234561
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect participant privacy and comply with ethical and legal regulations.
Publications
Hazar EB, Guder BC, Hazar K, Gok UD, Alkhamees NH, Ibrahim ZM, Al-Mhanna SB, Batrakoulis A. Upper extremity muscle thickness and grip strength following a boccia-based intervention in hemiparetic individuals. BMC Sports Sci Med Rehabil. 2026 Feb 16;18(1):170. doi: 10.1186/s13102-026-01601-3.
PubMed 41699666
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Boccia Exercises on Upper Extremity Muscle Thickness and Grip Strength in Hemiparetic Individuals: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07254273
- Acronym / sponsor ID
- E-15604681-100-234561
- Conditions
- Hemiparesis After Stroke
- Keywords
- Stroke, ultrasound, upper extremity, hemiparatic, muscle thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bayburt UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 28 Nov 2025 (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 investigates whether adding Boccia exercises to conventional rehabilitation improves upper extremity muscle thickness and grip strength in individuals with hemiparesis following stroke. The research aims to determine if Boccia training can enhance muscle morphology and functional strength beyond standard physical therapy.
Detailed description
Loss of upper extremity function after stroke significantly reduces independence in daily living. Changes in muscle morphology (muscle thickness, echogenicity, pennation, etc.) can affect strength, coordination, and functional performance. Boccia is a sport originally designed for individuals with special needs, encouraging hand-eye coordination, targeting, and force-controlled repetitions. Due to these characteristics, it has been suggested that boccia may positively impact both motor control and muscle tone; however, its effects on muscle morphology and grip strength in hemiparetic individuals have been limitedly studied. This study will investigate the contribution of boccia exercises to conventional physiotherapy on upper extremity muscle thickness and grip strength.
Primary objective: To evaluate whether boccia exercises provide significant improvements in upper extremity muscle thickness and grip strength after hemiparesis, in addition to conventional physical therapy.
Hypothesis: Participants who receive up to nine weeks of extended or eight weeks (8 weeks in the protocol) of boccia practice will show greater improvements in upper extremity muscle thickness and grip strength than those who receive conventional physical therapy alone.
This study is a parallel-group, random assignment controlled trial. The total sample included 22 stroke (hemiparetic) individuals; participants were randomly assigned to two groups: Boccia + physical therapy (Boc, n = 12) and physical therapy alone (Ctrl, n = 10). Assessments will be conducted at pre-intervention (baseline) and post-intervention (after 8 weeks). Assessors will be blinded to the measurements; complete blinding of operators and participants is not possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional Study Model: Design: Randomized Controlled, Parallel Assignment, Pretest-Posttest Design Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment / Rehabilitation
| Arm | Type | Receives |
|---|---|---|
| Boccia Exercise Group | Experimental | Other: Boccia exercise, Other: physiotherapyParticipants in this group will receive conventional physical therapy combined with Boccia exercises three times per week for 8 weeks. Each session lasts approximately 45-60 minutes and includes warm-up, Boccia skill drills (target aiming, throwing control), and cool-down activities. |
| Control Group | Active comparator | Other: physiotherapyParticipants in this group will receive only conventional physical therapy three times per week for 8 weeks. The program includes strengthening, range of motion, and task-specific functional exercises matched in duration and frequency to the experimental group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18-75
- Having had a stroke within the last 6-24 months and diagnosed with hemiparesis
- Mild to moderate motor function loss in the upper extremity (e.g., Fugl-Meyer Upper Extremity Score ≥ 20/66)
- Clinically stable individuals eligible to participate in sessions
- Be conscious, cognitively able to follow instructions, and consent
Key exclusion criteria (7 listed)
- Limited upper extremity movement due to severe spasticity, contracture, or joint deformity (Modified Ashworth Scale ≥ 3)
- Contraindication to exercise due to severe cardiovascular, pulmonary, or systemic disease
- Serious diseases other than neurological disorders (e.g., Parkinson's, MS, tumor)
- History of upper extremity surgery or trauma within the last 6 months
- Inability to exercise due to severe pain, infection, or skin lesions
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 |
|---|---|---|
| Boccia exerciseBoccia exercises differ significantly from other rehabilitation interventions for individuals with physical disabilities. Traditional physical therapy or exercise programs often involve repetitive, motivating movements that lack motivation and cannot be directly linked to individuals' daily activities. However, thanks to its game-based structure, Boccia offers a fun and functional exercise platform. This increases individuals' motivation to participate, facilitates continuity, and brings a more natural setting to the rehabilitation process. Furthermore, Boccia supports the active use of upper extremity muscles and the development of balance and coordination, while also encouraging social interaction and a sense of competition. Therefore, Boccia's game-based and accessible structure offers a more applicable and sustainable approach to developing motor skills and increasing functional independence in individuals with physical disabilities compared to other traditional interventions. | Other | Boccia Exercise Group |
| physiotherapyConventional physical therapy (physiotherapy) is a proven rehabilitation approach aimed at improving upper extremity function, muscle strength, and range of motion in hemiparetic individuals who have had a stroke. The program includes strengthening exercises, joint mobilization, task-oriented functional activities, and motor relearning techniques. Sessions are individualized and tailored to the participant's clinical condition to increase independent participation in activities of daily living in hemiparetic individuals. Regular and structured practice helps prevent the development of muscle atrophy and contractures and maximize functional gains. | Other | Boccia Exercise Group, Control Group |
Primary outcome
upper extremity muscle thickness
Time frame: 8 weeks
Muscle thickness of selected upper extremity muscles (e.g., biceps brachii, triceps brachii, deltoid) is measured using ultrasonography. Measurements are taken at standard anatomic locations with the participant in a relaxed, resting position. Thickness is recorded in millimeters (mm) and represents the distance between the superficial and deep aponeuroses of the muscle. Assessments are performed before (baseline) and after (8 weeks) the intervention by blinded assessors to assess changes in muscle morphology.
1 secondary outcome
Grip Strength
Time frame: 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 28 Nov 2025.
- Derived from this study: PubMed 41699666Hazar EB, Guder BC, Hazar K, Gok UD, Alkhamees NH, Ibrahim ZM, Al-Mhanna SB, Batrakoulis A. Upper extremity muscle thickness and grip strength following a boccia-based intervention in hemiparetic individuals. BMC Sports Sci Med Rehabil. 2026 Feb 16;18(1):170. doi: 10.1186/s13102-026-01601-3.
- Individual participant dataSharing planned: No. IPD will not be shared to protect participant privacy and comply with ethical and legal regulations.
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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.
EMRE B HAZAR, Master Degree principal investigator
Bayburt 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 Boccia exercise and physiotherapy in people with Hemiparesis After Stroke, run by Bayburt 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 6 inclusion and 7 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 28 Nov 2025. 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 muscle thickness (time frame: 8 weeks). 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 NCT07254273, 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 28 Nov 2025.