| CTRI Number |
CTRI/2025/07/090023 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Improving Grip Strength and Hand Use in People with Rheumatoid Arthritis Through Exercise |
|
Scientific Title of Study
|
Exercise Program To Improve Grip Strength And Hand
Function In Rheumatoid Arthritis Patients - A Quasi-
Experimental Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Motar Sublok |
| Designation |
Assistant Professor |
| Affiliation |
KLE College of Physiotherapy Hubballi. |
| Address |
KLE college of physiotherapy Hubballi
KLE college of physiotherapy Hubballi
Gabbur,Near Kundgol Cross, Kotgondhunshi, Hubbali -Bengaluru Highway
Dharwad
KARNATAKA
580028
India |
| Phone |
08369721874 |
| Fax |
|
| Email |
drpooja22@kledeemeduniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Motar Sublok |
| Designation |
Assistant Professor |
| Affiliation |
KLE College of Physiotherapy Hubballi. |
| Address |
KLE college of physiotherapy Hubballi
KLE college of physiotherapy Hubballi
Gabbur,Near Kundgol Cross, Kotgondhunshi, Hubbali -Bengaluru Highway
Dharwad
KARNATAKA
580028
India |
| Phone |
08369721874 |
| Fax |
|
| Email |
drpooja22@kledeemeduniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Motar Sublok |
| Designation |
Assistant Professor |
| Affiliation |
KLE College of Physiotherapy Hubballi. |
| Address |
KLE college of physiotherapy Hubballi
KLE college of physiotherapy Hubballi
Gabbur,Near Kundgol Cross, Kotgondhunshi, Hubbali -Bengaluru Highway
Dharwad
KARNATAKA
580028
India |
| Phone |
08369721874 |
| Fax |
|
| Email |
drpooja22@kledeemeduniversity.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR Pooja Motar Sublok |
| Address |
KLE college of physiotherapy Hubballi
Gabbur,Near Kundgol Cross, Kotgondhunshi, Hubbali -Bengaluru Highway |
| 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 Pooja Motar Sublok |
KLE Cooperative Hospital |
Shree Shakti Rd, New Hubli, Hubballi, Karnataka 580020, India
Dharwad
KARNATAKA |
8861987516
drpooja22@kledeemeduniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JGMM Medical College Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M055||Rheumatoid polyneuropathy with rheumatoid arthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise Therapy |
The participants will be treated with polypellets for 3 sessions per week, followed by a home exercise programme including tendon gliding, radial walking, intrinsic flexion, finger extension and abduction, thumb flexion, extension, adduction, abduction, gross grip, finger pinch grip, and fan and fist exercises. Each exercise will be performed for 8–10 repetitions, 3 sets per day. This exercise programme will be continued for 4 weeks. After 4 weeks of the exercise programme, the subjects will be reassessed for post-test measurements. The subjects will be advised to continue the exercises regularly.
During treatment with polypellets, the subjects will be instructed to sit in a relaxed position with the arm and forearm in an extended position and to hold and release the polypellets. This activity will help facilitate flexion and extension movements in their fingers and hands. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age Group ranging from 20-40 years. Diagnosed case of rheumatoid arthritis.
Patients who are having less hand grip strength.
Men
Female
Visual analogue scale (4-9).
Patient who are having swelling and pain in joints of the hands.
|
|
| ExclusionCriteria |
| Details |
Nerve injury and nerve palsy. Deformities of hand. History of Fracture.
Patients who are not willing to participate in these studies.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale, Michigan hand questionnaire, Hand grip strength |
Visual analogue scale, Michigan hand questionnaire, Hand grip strength at 0, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="8"
Sample Size from India="8"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/07/2026 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Rheumatoid arthritis is an auto-immune illness characterised
by joint inflammation, followed by cartilage degradation and bone erosion. The
cause of rheumatoid arthritis is not known, it may cause due to genetic and
disease primarily effecting the synovial membrane in joints andtendon sheets
and changes to rheumatoid synovitis, it increases the inflammation, oedema in
synovial tissues, the joint spacing will be become more due to more production
of synovial fluid. The normal fibres present in the joint will be affected by
the diseased synovial in the surrounding tendons and due to tendon stretching
the hand strength will be decreased and gradually it ruptures. Polypellets are
desensitization particles, helps to maintain range of motion, helps with pain,
and increases the superficial sensory and increases circulation (due to pumping
action). The strengthening exercises also help to increase the function of the hand
and maintain the range of motion, the patient have to continue their exercises
at home. The resistance exercises will mostly help to increases there range of
motion, by performing the exercises they will help to maintain proper hand
function and prevent the deformities of the hand. (Chadwick, A. 2004; Chung, K. C., Pillsbury, et al1998; Turner-Stokes, L.
1994).
|