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

August 13, 2026 updated by: Busra Turk, Istanbul University - Cerrahpasa
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: SMART-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.
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.
Behavioral: Conventional 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.
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.
Behavioral: SMART-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.
Behavioral: Joint 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 4, Week 8, and Week 12 (Primary endpoint: change from baseline to Week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 4, Week 8, and Week 12
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.
Baseline, Week 4, Week 8, and Week 12
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.
Baseline, Week 4, Week 8, and Week 12
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.
Baseline, Week 4, Week 8, and Week 12
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.
Baseline, Week 4, Week 8, and Week 12
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.
Baseline, Week 4, Week 8, and Week 12
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.
Baseline, Week 4, Week 8, and Week 12
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.
Baseline, Week 4, Week 8, and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 28, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

August 5, 2026

First Submitted That Met QC Criteria

August 7, 2026

First Posted (Actual)

August 10, 2026

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulUC-FTR-BT-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made publicly available. Data will be retained by the investigators in accordance with institutional policies and ethical approval, and no current plan exists for external data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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