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CTRI Number  CTRI/2025/08/092630 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 04/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study on the Effect of Machine-Guided Shoulder Exercises on Movement and Strength in Recreational Overhead Sport Players with Shoulder Internal Rotation Deficit. 
Scientific Title of Study   Effect of Isokinetic Dynamometer guided rehabilitation on Range of motion and Strength in recreational overhead athletes with GIRD : A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Samta Gandhi 
Designation  PG Student 
Affiliation  KLE Institute of Physiotherapy 
Address  KLEs Dr. Prabhakar Kore Hospital and Medical Research Center,
Room no. 39, Sagar Floor, Advanced Physiotherapy Centre, Department of Biomechanics Nehru Nagar
Belgaum
KARNATAKA
590010
India 
Phone  9110264363  
Fax    
Email  samtagandhi0047@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Samta Gandhi 
Designation  PG Student 
Affiliation  KLE Institute of Physiotherapy 
Address  KLEs Dr. Prabhakar Kore Hospital and Medical Research Center,
Room no. 39, Sagar Floor, Advanced Physiotherapy Centre, Department of Biomechanics Nehru Nagar

KARNATAKA
590010
India 
Phone  9110264363  
Fax    
Email  samtagandhi0047@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Varsha Huddar 
Designation  Assistant Professor 
Affiliation  KLE Institute of Physiotherapy 
Address  KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 39, Sagar Floor, Advanced Physiotherapy Centre, Department of Biomechanics, Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  09880733370  
Fax    
Email  varshahuddarklekipt@edu.in  
 
Source of Monetary or Material Support  
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center 
 
Primary Sponsor  
Name  Samta Gandhi 
Address  KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 39, Sagar Floor, Advanced Physiotherapy Centre, Department of Biomechanics, Belgaum, Karnataka Belgaum KARNATAKA 590010 India  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Samta Gandhi  KLEs Dr. Prabhakar Kore Hospital and Medical Research Cente  Room no. 39, Sagar Floor, Advanced Physiotherapy Centre, Department of Biomechanics
Belgaum
KARNATAKA 		 09110264363

samtagandhi0047@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical Committee KlE Institute of Physiotherapy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pathological Glenohumeral Internal Rotation deficit 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  The control group will undergo a progressive four-week resistance band exercise protocol targeting the shoulder internal and external rotator muscles. Participants will perform concentric shoulder internal rotation (IR) and eccentric shoulder external rotation (ER) exercises, with sessions conducted three times per week, each lasting approximately 50 minutes. Each session begins with a 10-minute warm-up session, followed by 30 minutes of intervention. In Week 1, both exercises performed using a light resistance band (yellow), with 10 repetitions for 3 sets for IR and 10 repetitions held for 5 seconds per rep across 3 sets for ER. In Week 2, the resistance was increased by progressing from the yellow to the red band while maintaining the same repetition scheme. Week 3 involved a further increase in resistance, progressing from the red to the blue band with the same volume. Finally, in Week 4, the volume was increased for the internal rotators to 4 sets of 10 repetitions, and the hold time for the external rotator exercise was extended to 10 seconds per repetition for 3 sets. Each session concludes with a 10-minute cool-down, with a 10-second rest between each set. 
Intervention  Isokinetic Dynamometer Guided Rehabilitation Protocol for GIRD  The intervention group will undergo a 4-week isokinetic rehabilitation program with sessions conducted three times per week, each lasting approximately 50 minutes. Each session begins with a 10-minute warm-up session. This is followed by a 30-minute isokinetic exercise intervention, targeting eccentric external rotation and concentric internal rotation using a dynamometer. The training intensity progresses weekly, beginning at 120°/sec in Week 1, decreasing to 90°/sec in Week 2, and reaching 60°/sec in Weeks 3 and 4. The dosage includes 5 repetitions × 3 sets for the first three weeks, and 5 repetitions × 4 sets in the final week, with a 10-second rest between each set. Each session concludes with a 10-minute cool-down. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  19 to 30-year-old overhead athletes of all genders.

Recreation athletes who participate in sports to improve their health, or just for enjoyment, has an intent to compete; exercise for equal to more than 4 hours per week, and participate in open events.

Pathological GIRD ,i.e., loss of glenohumeral internal rotation greater than 18 degree–20 degree in throwing shoulder compared to non throwing shoulder with a corresponding loss of the total rotation greater than 5 degree seen in both shoulders. 
 
ExclusionCriteria 
Details  History of upper limb injury in past one year.

Complain of pain in upper limb extremities since 6 months.

Structural abnormalities of upper limb.

Any surgery in the upper limb region in the past one year.

Participating in shoulder rehabilitation in the past year.

Diagnosed cases of neurological and musculoskeletal disorders that
limit upper limb movement. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
easytech primaDOC Isokinetic Dynamometer  Participants will be assessed for shoulder internal and external range of motion , peak torque of shoulder internal and external rotators at two time points: before intervention and after 4 weeks of the intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/09/2025 
Date of Study Completion (India) 10/03/2026 
Date of First Enrollment (Global)  20/09/2025 
Date of Study Completion (Global) 10/03/2026 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This randomized controlled trial aims to evaluate the effectiveness of isokinetic dynamometer-guided rehabilitation in improving shoulder range of motion (ROM) and muscle strength among recreational overhead athletes with Glenohumeral Internal Rotation Deficit (GIRD). Thirty-six participants aged 19–30 years with pathological GIRD will be recruited from colleges in Belagavi and randomly assigned to two groups: an intervention group receiving isokinetic-based rehabilitation and a control group undergoing traditional resistance band exercises. The study will measure pre- and post-intervention shoulder ROM and peak torque using the easytech primaDOC isokinetic dynamometer. The intervention will be conducted over four weeks, three sessions per week. This trial aims to assess the efficacy of a more objective and targeted rehabilitation approach to reduce injury risk and enhance performance in overhead athletes. 
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