Rheumatoid Arthritis, Rheumatoid Arthritis (RA, Rheumatoid Arthritis (RA) Prevention
Conditions
Keywords
Rheumatoid Arthritis, Hand Rehabilitation, Hand Function, Proprioception, Neuromuscular Control, Grip Strength, Joint Stability
Brief summary
Rheumatoid arthritis (RA) frequently affects the hand and wrist, resulting in pain, reduced joint stability, impaired proprioception, muscle weakness, and limitations in daily activities. Although conventional rehabilitation primarily focuses on range of motion and strengthening exercises, sensorimotor impairments such as proprioceptive deficits are often underaddressed. The SMART-HAND (Sensory, Massage, Approximation, ROM, Training = Strengthening + Perturbation) protocol was developed as a structured, mechanism-based rehabilitation program to improve proprioception, joint stability, motor control, and hand function. This randomized controlled trial aims to evaluate the effectiveness of the SMART-HAND protocol in individuals with RA by comparing its effects on hand function, proprioception, pain, dexterity, muscle strength, and functional performance with conventional rehabilitation and a control group.
Interventions
BEHAVIORALSMART-HAND Protocol
The SMART-HAND Protocol is a supervised, mechanism-based hand rehabilitation program administered twice weekly for 12 weeks (24 sessions, 50 minutes per session). The protocol consists of sensory training, massage, joint approximation, range of motion exercises, stretching, strengthening exercises, and perturbation-based stabilization training. Exercise progression is individualized according to participants' tolerance using the Borg Rating of Perceived Exertion scale and progressive resistance. The intervention is designed to improve proprioception, sensorimotor control, joint stability, muscle strength, and hand function.
BEHAVIORALConventional Hand Rehabilitation
Participants will receive a supervised conventional hand rehabilitation program twice weekly for 12 weeks (24 sessions, 50 minutes per session). The program includes range of motion, stretching, and strengthening exercises. Exercise intensity and progression will be individualized according to participants' tolerance using the Borg Rating of Perceived Exertion scale and progressive resistance.
BEHAVIORALJoint Protection and Ergonomic Education
Participants will receive a single face-to-face education session lasting approximately 20-30 minutes. The education will include information on joint protection techniques, ergonomic principles, energy conservation, and recommendations for performing activities of daily living. Participants will continue their routine medical care throughout the study but will not receive a supervised exercise program.
Sponsors
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessments will be performed by an independent assessor who will be blinded to group allocation. Statistical analyses will be conducted by an independent statistician blinded to treatment allocation. Participants and treating physiotherapists cannot be blinded because of the nature of the interventions.
Intervention model description
Participants will be randomly assigned to one of three parallel groups: (1) the SMART-HAND protocol group, (2) the conventional hand rehabilitation group, or (3) the control group. The intervention will be administered for 12 weeks, and outcome measures will be assessed at baseline and at the end of the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants will be 18 years of age or older. * Participants will have a diagnosis of rheumatoid arthritis for at least five years. * Participants will be referred by a rheumatologist. * Participants will have been on a stable medication regimen for the past three months. * Participants will have no history of diabetes mellitus. * Participants will have no other conditions affecting sensory function. * Participants will provide informed consent to participate in the study.
Exclusion criteria
* Individuals who have undergone hand surgery within the past six months. * Individuals with a history of upper extremity fracture within the past six months. * Individuals with other musculoskeletal pain conditions involving the muscles and/or joints. * Individuals diagnosed with a neurological disease that may affect sensory or motor function. * Individuals who are unable to fully cooperate with the assessment procedures. * Individuals who have received corticosteroid treatment within the past month. * Individuals diagnosed with another rheumatic disease. * Pregnant women. * Individuals who are illiterate. Withdrawal/Discontinuation Criteria * Participants who miss more than 10% of the intervention sessions will be excluded from the study. * Participants who change their medication dosage or medication class during the study period will be excluded from the study. * Participants will have the right to withdraw from the study at any time and for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Michigan Hand Outcomes Questionnaire (MHQ) | Baseline, Week 4, Week 8, and Week 12 (Primary endpoint: change from baseline to Week 12) | The Michigan Hand Outcomes Questionnaire (MHQ) will be used to assess hand function, activities of daily living, pain, work performance, aesthetics, and patient satisfaction. The primary endpoint is the change in the total MHQ score from baseline to Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Joint Position Sense (Proprioception) | Baseline, Week 4, Week 8, and Week 12 | Wrist, metacarpophalangeal (MCP), and proximal interphalangeal (PIP) joint proprioception will be assessed using a joint position reproduction test with a goniometer. The mean absolute repositioning error from three trials will be recorded. |
| Nine-Hole Peg Test | Baseline, Week 4, Week 8, and Week 12 | Hand dexterity will be assessed using the Nine-Hole Peg Test. The average completion time of two trials for each hand will be recorded in seconds. |
| Duruöz Hand Index | Baseline, Week 4, Week 8, and Week 12 | Hand functional disability will be evaluated using the Duruöz Hand Index. Higher scores indicate greater disability. |
| Pain Intensity | Baseline, Week 4, Week 8, and Week 12 | Pain intensity during rest, activity, and night will be assessed using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain. |
| Sensory Threshold | Baseline, Week 4, Week 8, and Week 12 | Cutaneous sensory threshold will be evaluated using Semmes-Weinstein monofilaments. The thinnest monofilament perceived by the participant will be recorded. |
| Grip Strength | Baseline, Week 4, Week 8, and Week 12 | Maximum hand grip strength will be measured using a Jamar dynamometer. The average of three maximal contractions will be recorded in kilograms. |
| Pinch Strength | Baseline, Week 4, Week 8, and Week 12 | Lateral pinch and three-jaw chuck pinch strength will be measured using a Baseline pinch gauge. The average of three trials will be recorded in kilograms-force. |
| Range of Motion | Baseline, Week 4, Week 8, and Week 12 | Active range of motion of the wrist and finger joints will be measured using standard goniometers and recorded in degrees. |
Contacts
CONTACTBusra Turk, PT, MSc
Outcome results
None listed