Development and Evaluation of the Effectiveness of the SMART-HAND Protocol for Hand Rehabilitation in Patients With Rheumatoid Arthritis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstanbul University - Cerrahpasa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SMART-HAND Protocol

    Behavioral

    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.

  • Conventional Hand Rehabilitation

    Behavioral

    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.

  • Joint Protection and Ergonomic Education

    Behavioral

    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.

Treatment groups

132 Participants
are divided into 3 treatment groups
Group A: SMART-HAND ProtocolExperimental treatment 1 intervention
Group B: Conventional Hand Rehabilitation GroupActive comparator 1 intervention
Group C: Usual Care + Education GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Michigan Hand Outcomes Questionnaire (MHQ)

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.

Time frame
Baseline, Week 4, Week 8, and Week 12 (Primary endpoint: change from baseline to Week 12)

Secondary outcomes

1

Joint Position Sense (Proprioception)

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.

Time frame
Baseline, Week 4, Week 8, and Week 12
2

Nine-Hole Peg Test

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.

Time frame
Baseline, Week 4, Week 8, and Week 12
3

Duruöz Hand Index

Hand functional disability will be evaluated using the Duruöz Hand Index. Higher scores indicate greater disability.

Time frame
Baseline, Week 4, Week 8, and Week 12
4

Pain Intensity

Pain intensity during rest, activity, and night will be assessed using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain.

Time frame
Baseline, Week 4, Week 8, and Week 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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