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

Sponsor
Istanbul University - Cerrahpasa
Study ID
NCT07754552
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 10, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Dec 28, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SMART-HAND Protocol
    Participants assigned to the SMART-HAND Protocol Group will receive a supervised 12-week hand rehabilitation program consisting of two 50-minute sessions per week (24 sessions in total). The SMART-HAND protocol includes massage, sensory training, joint approximation, range of motion exercises, stretching, strengthening exercises, and perturbation-based stabilization training. Exercise progression will be individualized according to participants' tolerance using the Borg Rating of Perceived Exertion scale and progressive resistance. The intervention is designed to improve proprioception, sensorimotor integration, dynamic joint stability, muscle strength, and hand function.
  • Active Comparator: Conventional Hand Rehabilitation Group
    Participants assigned to the Conventional Hand Rehabilitation Group will receive a supervised 12-week conventional hand exercise program consisting of two 50-minute sessions per week (24 sessions in total). 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. The intervention primarily aims to improve joint mobility, muscle strength, and hand function.
  • Active Comparator: Usual Care + Education Group
    Participants assigned to the Usual Care + Education Group will continue to receive their routine medical care and will attend a single educational session lasting approximately 20-30 minutes. The education will include joint protection principles, ergonomic recommendations, and strategies for performing activities of daily living. No supervised exercise program will be provided during the 12-week study period.

Primary Outcome Measure

Michigan Hand Outcomes Questionnaire (MHQ) [ Time Frame: Baseline, Week 4, Week 8, and Week 12 (Primary endpoint: change from baseline to Week 12) ]

Central Contacts

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