Effects of Boccia Exercises on Upper Extremity Muscle Thickness and Grip Strength in Hemiparetic Individuals: A Randomized Controlled Trial
Phase: NA
Conditions: Hemiparesis After Stroke
Sponsor: Bayburt University

Official Study Title: Effects of Boccia Exercises on Upper Extremity Muscle Thickness and Grip 
Strength in Hemiparetic Individuals 
NCT Number: NCT ID not yet assigned 
Document Type: Study Protocol with Statistical Analysis Plan (SAP) 
Document Date: 15 November 2025 
Principal Investigator: Emre Berk HAZAR 
Institution: Bayburt University 
 
 

Study Protocol with Statistical Analysis Plan: Effects of Boccia Exercises on Upper Extremity 
Muscle Thickness and Grip Strength in Hemiparetic Individuals 
Study Design 
This is a randomized controlled trial (RCT) with a true experimental pretest-posttest control group 
design. The study aims to examine the effects of an 8-week Boccia exercise program on upper 
extremity muscle architecture and grip strength in hemiparetic individuals, in addition to their ongoing 
rehabilitation program. 
 
Duration: 8 weeks 
 
Frequency: 3 sessions per week for both physical therapy and Boccia exercises 
 
Groups: 
o 
Experimental Group: Physical therapy + Boccia exercises 
o 
Control Group: Physical therapy only 
To standardize measurements, participants refrained from physical therapy sessions for 48 hours prior 
to assessment and avoided caffeine and alcohol for 24 hours. Two independent evaluators ensured 
blinding: Evaluator 1 conducted all measurements, while Evaluator 2 administered the Boccia 
program. 
Participants 
 
Population: Adults aged 18–75 with hemiparesis post-stroke (6–24 months post-event) 
 
Inclusion Criteria: Clinically stable, able to follow instructions, attend sessions, and provide 
consent 
 
Exclusion Criteria: Severe spasticity, major comorbidities, recent upper extremity surgery, 
severe cognitive impairment, or participation in other trials 
Interventions 
Boccia Exercise Group (Experimental) 
 
Weeks 1–2: Flexibility training and introduction to basic Boccia throwing techniques 
 
Weeks 3–8: Physical therapy sessions plus one Boccia session per day; progressive 
complexity in throwing techniques, including tactical training and match play 
 
Supervision: Each session led by a physiotherapist and Boccia coach 
 
Session Duration: ~1 hour 
Control Group 
 
Conventional physical therapy only: strengthening, range of motion, motor retraining, and 
functional exercises matched for duration and frequency 
Outcome Measures 
Primary Outcome 
Grip Strength 
 
Measured with a Jamar Hydraulic Hand Dynamometer 
 
Participant seated with elbow at 90°, forearm neutral, wrist 0–30° extension 
 
Three trials per assessment; highest value recorded (kg) 

 
Assessment Timepoints: Baseline and post-intervention (8 weeks) 
Secondary Outcome 
Upper Extremity Muscle Thickness 
 
Measured using B-mode ultrasonography (SonoHealth dual-sector + linear probe) 
 
Muscles assessed: biceps brachii, brachialis, triceps brachii, anterior deltoid, forearm and hand 
muscles 
 
Measurement points standardized using anatomical landmarks 
 
Three images per site; average used for analysis (mm) 
 
Assessment Timepoints: Baseline and post-intervention 
Statistical Analysis 
 
Conducted with IBM SPSS v21.0 
 
Normality tested with Shapiro-Wilk 
 
Categorical variables compared with Chi-square or Fisher’s exact test 
 
Changes over time and between groups evaluated with two-way repeated measures ANOVA 
(2 × 2) 
 
Post hoc analyses applied if significant Time × Group interaction detected 
 
Significance Level: p ≤ 0.05 
Randomization & Blinding 
 
Participants randomly allocated to experimental or control groups 
 
Evaluator 1 blinded to group allocation 
 
Evaluator 2 administered Boccia exercises exclusively 
 
Participants aware of their intervention (cannot be blinded) 
Safety & Monitoring 
 
All participants monitored for adverse events 
 
Physiotherapist present during all sessions to minimize risk of injury 
 
Session adherence and tolerance recorded 
Ethics & Data Management 
 
Informed consent obtained from all participants 
 
Collected data anonymized for analysis 
 
Data stored securely and used solely for research purposes