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NCT Number: NCT07754552

DEVELOPMENT AND EVALUATION OF THE EFFECTIVENESS OF THE SMART-HAND PROTOCOL FOR HAND REHABILITATION IN PATIENTS WITH RHEUMATOID ARTHRITIS

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis (RA Rheumatoid Arthritis (RA) Prevention Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants will consist of individuals aged 18 years and older who have been diagnosed with rheumatoid arthritis at least five years prior to enrollment and referred by a rheumatologist. Eligible participants must have been on a stable medication regimen for the past three months, have no history of diabetes or other conditions affecting sensory function, and provide informed consent to participate.

Exclusion criteria

  • Individuals who have undergone hand surgery within the past six months, have a history of upper extremity fracture within the last six months, or have other pain conditions involving muscles and/or joints will be excluded. Additionally, individuals diagnosed with a neurological disease that may affect sensory or motor function, those unable to fully cooperate with the assessment procedures, those who have received corticosteroid treatment within the past month, those diagnosed with another rheumatic disease, pregnant women, and individuals who are illiterate will not be included in the study.

Furthermore, participants who miss more than 10% of the intervention sessions or who change their medication dosage or class during the study period will be excluded. Participants will have the right to withdraw from the study at any time for any reason.

Treatment and study plan

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.

Primary outcomes

  1. Michigan Hand Outcomes Questionnaire (MHQ)

    Time frame: 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 outcomes

  1. Joint Position Sense (Proprioception)

    Time frame: 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.

  2. Nine-Hole Peg Test

    Time frame: 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.

  3. Duruöz Hand Index

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

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

  4. Pain Intensity

    Time frame: 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.

  5. Sensory Threshold

    Time frame: 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.

  6. Grip Strength

    Time frame: 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.

  7. Pinch Strength

    Time frame: 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.

  8. Range of Motion

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Busra Turk, PT, MSc

CONTACT

[email protected]

+905448744200

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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