CTRI

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CTRI Number

CTRI/2025/09/094083 [Registered on: 02/09/2025] Trial Registered Prospectively

Last Modified On:

26/08/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Study on People with Traumatic Brachial Plexus Injury: How Difficulties in Daily Activities Affect Social Participation

Scientific Title of Study

Relationship Between Functional Limitations And Social Participation In Individuals With Traumatic Brachial Plexus Injury

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	S Sowjanya Nayak
Designation	Postgraduate Student
Affiliation	Manipal College Of Health Professions
Address	Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal Udupi KARNATAKA 576104 India
Phone	9108886323
Fax
Email	sowjanya.mchpmpl2024@learner.manipal.edu

Details of Contact Person
Scientific Query

Name	Dr Shovan Saha
Designation	Associate Professor
Affiliation	Manipal College Of Health Professions
Address	Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal Udupi KARNATAKA 576104 India
Phone	09108886323
Fax
Email	shovan.saha@manipal.edu

Details of Contact Person
Public Query

Name	Dr Shovan Saha
Designation	Associate Professor
Affiliation	Manipal College Of Health Professions
Address	Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal Udupi KARNATAKA 576104 India
Phone	09108886323
Fax
Email	shovan.saha@manipal.edu

Source of Monetary or Material Support

Kasturba Hospital, Udupi-hebri road, Madhav Nagar, Manipal, Karnataka, India-576104

Primary Sponsor

Name	Kasturba Hospital
Address	Kasturba Hospital, Udupi-hebri road, Madhav Nagar, Manipal, Karnataka- 576104
Type of Sponsor	Private hospital/clinic

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 S Sowjanya Nayak	Kasturba Hospital	Department of Occupational Therapy, N1 Baliga Block, Kasturba Hospital, Udupi- Hebri road, Madhav Nagar, Manipal, Karnataka-576104 Udupi KARNATAKA	9108886323 sowjanya.mchpmpl2024@learner.manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: S143\|\|Injury of brachial plexus,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Who can read and understand English or Kannada. Individuals with unilateral traumatic brachial plexus injury post-surgery, 3 months to 12 months.

ExclusionCriteria

Details

Pre-existing upper limb condition.
Individuals diagnosed with psychiatric conditions such as social anxiety, depression

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1. Upper Extremity Functional Index tool to assess functional limitations 2. Participation scale to assess the degree of participation restriction. 3. 20 item short form survey to assess health related quality of life	Baseline

Secondary Outcome

Outcome	TimePoints
•To assess overall health-related QoL in individuals with traumatic brachial plexus injury	Baseline

Target Sample Size

Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

08/09/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="9"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

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 study addresses the impact of traumatic brachial plexus injuries (tBPI) on social participation in India, a collectivist society where interdependence is crucial. With tBPI cases rising, especially among young individuals in their most socially and economically active years, understanding this relationship is essential. Existing research is limited and primarily Western, making it necessary to explore how functional limitations affect social participation in the Indian context. This study will help bridge the gap in rehabilitation strategies and promote inclusive social policies for individuals with disabilities.

Aim: To identify relationship between functional limitations and social participation in individuals with traumatic brachial plexus injuries (tBPI).

Objectives:

Primary objectives:

· To assess the degree of functional limitations in individuals with tBPI.

· To evaluate the level of restrictions in social participation with tBPI.

Secondary objective:

· To assess overall health-related QoL in individuals with tBPI.