Boccia Exercises and Upper Limb Muscle Adaptations in Hemiparetic Individuals

NCT ID: NCT07254273

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-24
• Study Completion Date: 2025-01-20

Brief 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. 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.

Conditions

Hemiparesis After Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Boccia Exercise Group

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.

Group Type: EXPERIMENTAL

Boccia exercise

Intervention Type: OTHER

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.

physiotherapy

Intervention Type: OTHER

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.

Control Group

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.

Group Type: ACTIVE_COMPARATOR

physiotherapy

Intervention Type: OTHER

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.

Interventions

Boccia exercise

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.

Intervention Type: OTHER

physiotherapy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayburt University

OTHER

Sponsor Role: lead

Responsible Party

Emre Berk HAZAR

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

EMRE B HAZAR, Master Degree

Role: PRINCIPAL_INVESTIGATOR

Bayburt University

Locations

Bayburt Unıversity

Bayburt, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Study Documents

Document Type: Individual Participant Data Set

https://docs.google.com/spreadsheets/d/1ZN1TbLb\_kPid\_fZNsQVWYNu02qO5s-mv/edit?usp=sharing\&ouid=107542558214893941575\&rtpof=true\&sd=true

View Document

Other Identifiers

E-15604681-100-234561

Identifier Type: -

Identifier Source: org_study_id