CTRI

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CTRI Number

CTRI/2024/02/062993 [Registered on: 21/02/2024] Trial Registered Prospectively

Last Modified On:

07/02/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Effectiveness of a new exercise program for hand function among persons with type 2 diabetes mellitus

Scientific Title of Study

Effectiveness of a new exercise program on hand muscle strength, dexterity and function among persons with type 2 diabetes mellitus in central part of Kerala

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Anila Paul
Designation	Professor HOD
Affiliation	Medical Trust Institute of Medical Sciences, Medical Trust Hospital,
Address	Medical Trust Institute of Medical Sciences, College of Physiotherapy, Department of Musculoskeletal and Sports Physiotherapy, 5th floor, Irimpanam, Kochi, Kerala, India Ernakulam KERALA 682309 India
Phone	8547992248
Fax
Email	anu27paul@yahoo.co.in

Details of Contact Person
Scientific Query

Name	Dr Kumari Indira K S
Designation	Professor
Affiliation	Kerala university of health sciences
Address	Department of Respiratory Medicine Sree Narayana institute of medical sciences North Kuthiathode Ernakulam Kerala Ernakulam KERALA 683594 India
Phone	9349252112
Fax
Email	indiraks.dr@gmail.com

Details of Contact Person
Public Query

Name	Anila Paul
Designation	Professor HOD
Affiliation	Medical Trust Institute of Medical Sciences, Medical Trust Hospital,
Address	Medical Trust Institute of Medical Sciences, College of Physiotherapy, Department of Musculoskeletal and Sports Physiotherapy, 5th floor, Irimpanam, Kochi, Kerala, India Ernakulam KERALA 682309 India
Phone	8547992248
Fax
Email	anu27paul@yahoo.co.in

Source of Monetary or Material Support

Medical Trust Institute of Medical Sciences Kochi

Primary Sponsor

Name	Anila Paul
Address	Medical Trust Institute of Medical Sciences, College of Physiotherapy, Kochi, Kerala
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 Anila Paul PT	Medical Trust Hospital	MTIMS College of Physiotherapy Department of musculoskeletal and sports physiotherapy 5th floor Irumpanam Kochi Kerala Ernakulam KERALA	8547992248 04842843129 anu27paul@yahoo.co.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Medical Trust Hospital	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E118\|\|Type 2 diabetes mellitus with unspecified complications,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Conventional hand exercises	Active range of motion exercise for wrist joint- 2 sets of 10 repetitions each in both hands. Rest period of 3 minutes will be advised between the sets. Squeeze ball exercise, Rubber band exercise - hold for 10 seconds for 10 repetitions
Intervention	Exercise program for hand	Wrist joint flexion and extension on both hands, Wrist joint radial and ulnar deviation on both hands, Flexor tendon gliding and blocking exercises on both hands, Dosimetry for the above exercises are, 1-4 weeks: 2 sets of 10 repetitions 5-8 weeks: 3 sets of 15 repetitions Rest period of 3 minutes will be advised between the sets of exercises Squeeze Thera band exerciser ball to 50 percentage depression in palm of hand on both sides, Squeeze Thera band exerciser ball to 50 percentage depression between thumb and each finger in both hands, Isometric exercises for the flexors and extensors with resistance on the ventral and dorsal aspects of fingers, Rubber band exercise for finger abductors, Dosimetry for these exercises are 1-4 weeks: 2 sets of 10 repetitions, hold for 10 sec 5-8 weeks: 3 sets of 15 repetitions, hold for 10 sec Rest period of 3 minutes will be advised between the sets of exercises Functional task exercises Transfer bottle filled with water from one hand to other Crumple a sheet of newspaper into a ball and try to spread it back to a flat piece of paper Stacking coins Stack 10 one rupee coins from the table and back Turning pages Turn the pages one at a time of a 50 pages book Roll a pencil between thumb and each finger Lock and unlock with key, Dosimetry for functional exercises are, 1-4 weeks: 2 sets of 10 repetitions 5-8 weeks: 3 sets of 15 repetitions Rest period of 3 minutes will be advised between the sets of exercises

Inclusion Criteria

Age From	50.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Persons who are clinically diagnosed with type 2 diabetes mellitus and age between 50 and 70 years Both genders Persons who are under oral hypoglycemic drugs and or insulin Screening tests for musculoskeletal manifestations Prayer sign or Preachers sign positive and or Table top sign positive Hand muscle grip strength lower than 27 kg in males and 21 kg in females on dominant hand using hand held dynamometer. based on established normal values in Indian population Hand palmar pinch strength lower than 4 kg in males and 2 kg in females on dominant hand using pinch gauge. based on established normal values in Indian population Hand gross dexterity lower than 73 blocks in one minute in males and 75 blocks per minute in females on dominant hand using box and block test Hand fine dexterity more than 20 seconds in males and 18 seconds in females on dominant hand using nine hole peg test

ExclusionCriteria

Details

Musculoskeletal neurological metastatic involvement of cervical spine or upper extremity
Peripheral nerve injury affecting upper limb in past 6 months
History of wrist and hand trauma or surgery in past 3 months
Rheumatic degenerative disease and other musculoskeletal and neurological diseases
Impairments affecting upper extremity due to central peripheral or autonomic nervous system
MMSE score less than 24 showing impairment in cognition
Amputation joint fusion upper limb arthroplasty
Recent upper limb fractures and or surgeries in past 6 months
Reflex sympathetic dystrophy
History of diabetic complications like severe nephropathy severe retinopathy and significant cardio vascular impairments

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Hand muscle grip strength Pinch strength Hand gross dexterity Fine hand dexterity	At baseline - pre-test assessment At 8 weeks - Post test assessment

Secondary Outcome

Outcome	TimePoints
Hand functional activity Hand joint mobility Hand sensory neuropathy score	At baseline - pretest assessment At 8 weeks - post test assessment

Target Sample Size

Total Sample Size="10"
Sample Size from India="10"
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

Phase 2

Date of First Enrollment (India)

21/02/2024

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="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

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

Type 2 diabetes mellitus is reported to be one of the highly prevalent metabolic disease across the globe especially in developing countries like India. Scientific literature reported that the hand function, strength and dexterity are affected in type 2 diabetes mellitus which can impair the activities of daily living. There is scarcity of literature on exercise interventions to improve hand function in persons with type 2 diabetes. Therefore this study is designed to develop a structured exercise program incorporating all aspects of hand function like muscle strength, dexterity, flexibility and functional training.

The phase 1 of the study is designed to develop the exercise program for hand function and validate it through face, content and construct validation process. Phase 2 will be implementation of the exercise program on target population to investigate the effect of the new exercise program on hand functions among persons with type 2 diabetes mellitus.