NCT07254273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2024

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

8 days

First QC Date

November 13, 2025

Last Update Submit

November 19, 2025

Conditions

Keywords

Strokeultrasoundupper extremityhemiparaticmuscle thickness

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Secondary Outcomes (1)

  • Grip Strength

    8 weeks

Study Arms (2)

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.

Other: Boccia exerciseOther: 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.

Other: physiotherapy

Interventions

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.

Boccia Exercise Group

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.

Boccia Exercise GroupControl Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayburt Unıversity

Bayburt, Merkez, 69000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • EMRE B HAZAR, Master Degree

    Bayburt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 28, 2025

Study Start

October 24, 2024

Primary Completion

November 1, 2024

Study Completion

January 20, 2025

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

IPD will not be shared to protect participant privacy and comply with ethical and legal regulations.

Available IPD Datasets

Individual Participant Data Set (The individual participant dat)Access

Locations