| CTRI Number |
CTRI/2024/03/063941 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| 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
|
Effect of Exercise Intervention on Arthritis of Hand |
|
Scientific Title of Study
|
Efficacy of Structured Exercise Protocol on hand dysfunction in Patients with Rheumatoid Arthritis of hand– 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 |
Rutuja Rahul Raka |
| Designation |
PG Student |
| Affiliation |
Pravara Institute of Medical Sciences |
| Address |
Nagar Manmad Highway At Post Chincholi Phata
Taluka Rahuri
District Ahmadnagar
413710
Nagar Manmad Highway At Post Chincholi Phata
Taluka Rahuri
District Ahmadnagar
413710
Ahmadnagar
MAHARASHTRA
413710
India |
| Phone |
7447282223 |
| Fax |
|
| Email |
rutujarraka256@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukhpreet Pabla |
| Designation |
Assistant Proffesor |
| Affiliation |
Dr APJ Abdul Kalam college of Physiotherapy |
| Address |
OPD NO 403 Department of Orthopedic Physiotherapy fourth floor
DR APJ Abdul Kalam college of physiotherapy
OPD NO 403 Department of Orthopedic Physiotherapy fourth floor
DR APJ Abdul Kalam college of physiotherapy
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9638299273 |
| Fax |
|
| Email |
pablasukhpreet27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukhpreet Pabla |
| Designation |
Assistant Proffesor |
| Affiliation |
Dr APJ Abdul Kalam College of Physiotherapy |
| Address |
OPD NO 403 Department of Orthopedic Physiotherapy fourth floor
DR APJ Abdul Kalam College Of Physiotherapy
OPD NO 403 Department of Orthopedic Physiotherapy fourth floor
DR APJ Abdul Kalam College Of Physiotherapy
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
963829927 |
| Fax |
|
| Email |
pablasukhpreet27@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr APJ Abdul Kalam College of Physiotherapy |
| Address |
Dr APJ Abdul Kalam College of Physiotherapy Loni Bk 413736 Taluka Rahata District Ahmadnagar Maharashtra State |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rutuja Rahul Raka |
Dr APJ Abdul Kalam College of Physiotherapy |
OPD No 403 Department of Orthopeadic Physiotherapy Fourth Floor Dr APJ Abdul Kalam College of Physiotherapy
Ahmadnagar
MAHARASHTRA |
7447282223
rutujarraka256@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE OF INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M058||Other rheumatoid arthritis with rheumatoid factor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Exercises |
HOT WATER FERMENTATION 8/10 MINS 3DAYS/WEEK
HAND RANGE OF MOTION EXERCISES 10REPS 2SETS 3DAYS/WEEK
SRENTHENING EXERCISES 3DAYS/WEEK |
| Intervention |
Strenthening And Mobility Exercises |
Exercise Type Exercise Frequency sets Repetitions Initial hold Time Progression
Warm Up Joint Movement
Wrist flexion and
extension
Finger Opposition
Mass Grasp
Finger adduction
and abduction 3days /week 5mins
Mobility MCP flexion
Tendon gliding
Finger radial walking 10mins
Wrist circumduction
Finger abduction
3days /week
1 X5 5 second where required 10mins Step 1: in
Step 2: increase up to 10-second holds
Strength Eccentric wrist extension
Gross grip
Finger adduction 10mins
Pinch grip
Theraputty exercises 3days /week
(minimum 8 repetitions; maximum 12 repetitions)
Cool Down Stretch
Biceps
Triceps
Bracioradialis 5 mins
Forearm flexors
and extensors 3days /week
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants who are Conform diagnosed with Rheumatoid Arthritis according to ACR.
Age Greater than 18 years.
Males and females.
No treatment with DMARD or having stable DMARD for 3 months.
Pain and Dysfunction of hand / wrist joint.
|
|
| ExclusionCriteria |
| Details |
Participants who are not willing to participate in study
Unstable Acute Disease.
Metabolic Disorder
Recent Injuries
Age less than 18 years
Upper limb joint surgery or fracture
Chronic heart Failure
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analog Scale
Hand Dynamometer
Sollerman Hand Questionnaire |
Data Will be Recorded at baseline after 2 week and 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
19/03/2024 |
| 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="0"
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
|
Efficacy of structured exercise protocol on Hand Dysfunction in patients with Rheumatoid Arthritis of Hand A Randomized Controlled Trial NEED FOR THE STUDY: Literature reports a wide range of point and period prevalence of 0.46% Rheumatoid Arthritis affects the functional status,work performance and quality of life in individuals for longer period of time A well design protocol aims to address muscle weakness and reduce the impact of Rheumatoid Arthritis it promots better mobility and functionality for individuals affected by this condition The Purpose of the structured rehabilitation protocol is to evaluate the effect of strengthening exercises for increasing muscle strength .Therefore this self structured protocol is designed to overcome these challenges and helps an individual to lead a contemporary life. RESEARCH QUESTION Is there any effect of Structured exercise protocol on hand dysfunction in patients with Rheumatoid Arthritis of hand? AIM AND OBJECTIVES AIM To find the efficacy of Structured exercise protocol on hand dysfunction in patients with Rheumatoid Arthritis of hand OBJECTIVES 1. To Study the effect of Exercise protocol on Pain using Visual Analog Scale. 2. To Study the effect of Exercise protocol on Grip Funtion by using Sollerman hand Questionnaire. 3. To Study the effect of Exercise protocol on Strength using hand dynamometer. Hypotheses Null Hypothesis (H0) There will not be any significant effect of exercise protocol on hand dysfunction in improving Range of motion ,reduction in pain in patients with Rheumatoid Arthritis of hand Alternative Hypothesis (H1) There will be effect of exercise protocol on hand dysfunction in improving Range of motion ,reduction in pain in patients with Rheumatoid Arthritis of hand
Materials and Equipment’s to be used: Consent form Assessment sheet Questionnaire Hand Dynamometer ELIGIBLITY CRITERIA Inclusion criteria Ø Participants who are Conform diagnosed with Rheumatoid Arthritis according to ACR. Ø Age Greater than 18 years. Ø Males and females. Ø No treatment with DMARD or having stable DMARD for 3 months. Ø Pain and Dysfunction of hand / wrist joint. Exclusion criteria Participants excluded will be: Ø Participants who are not willing to participate in study Ø Unstable Acute Disease. Ø Metabolic Disorder Ø Recent Injuries Ø Age less than 18 years Ø Upper limb joint surgery or fracture Ø Chronic heart Failure Materials and Equipment’s to be used: Consent form Assessment sheet Questionnaire Hand Dynamometer | warm up | Joint Movement Wrist flexion and extension Finger Opposition Mass Grasp Finger adduction and abduction | | Mobility | MCP flexion Tendon gliding Finger radial walking Wrist circumduction Finger abduction | | Strength | Eccentric wrist extension Gross grip Finger adduction Pinch grip | | Cool Down | Stretch Biceps Triceps Bracioradialis Forearm flexors and extensors |
|