DEVELOPMENT AND EVALUATION OF THE EFFECTIVENESS OF THE SMART-HAND PROTOCOL FOR HAND REHABILITATION IN PATIENTS WITH RHEUMATOID ARTHRITIS
1 other identifier
interventional
132
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable rheumatoid-arthritis
Started Oct 2026
Shorter than P25 for not_applicable rheumatoid-arthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2026
CompletedFirst Posted
Study publicly available on registry
August 10, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2027
Study Completion
Last participant's last visit for all outcomes
December 30, 2027
August 10, 2026
August 1, 2026
1.2 years
August 5, 2026
August 7, 2026
Conditions
Keywords
Outcome Measures
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.
Baseline, Week 4, Week 8, and Week 12 (Primary endpoint: change from baseline to Week 12)
Secondary Outcomes (8)
Joint Position Sense (Proprioception)
Baseline, Week 4, Week 8, and Week 12
Nine-Hole Peg Test
Baseline, Week 4, Week 8, and Week 12
Duruöz Hand Index
Baseline, Week 4, Week 8, and Week 12
Pain Intensity
Baseline, Week 4, Week 8, and Week 12
Sensory Threshold
Baseline, Week 4, Week 8, and Week 12
- +3 more secondary outcomes
Study Arms (3)
SMART-HAND Protocol
EXPERIMENTALParticipants 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.
Conventional Hand Rehabilitation Group
ACTIVE COMPARATORParticipants 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.
Usual Care + Education Group
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (14)
Chua M, Seth I, Rozen WM. The reliability and applicability of the Ten Test in hand injuries: A systematic review. Hand Ther. 2024 Jun;29(2):44-51. doi: 10.1177/17589983241230249. Epub 2024 Jan 28.
PMID: 38827650RESULTJerosch-Herold C. Assessment of sensibility after nerve injury and repair: a systematic review of evidence for validity, reliability and responsiveness of tests. J Hand Surg Br. 2005 Jun;30(3):252-64. doi: 10.1016/j.jhsb.2004.12.006.
PMID: 15862365RESULTHillier S, Immink M, Thewlis D. Assessing Proprioception: A Systematic Review of Possibilities. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):933-49. doi: 10.1177/1545968315573055. Epub 2015 Feb 23.
PMID: 25712470RESULTLewis E, Fors L, Tharion WJ. Interrater and intrarater reliability of finger goniometric measurements. Am J Occup Ther. 2010 Jul-Aug;64(4):555-61. doi: 10.5014/ajot.2010.09028.
PMID: 20825126RESULTCarter TI, Pansy B, Wolff AL, Hillstrom HJ, Backus SI, Lenhoff M, Wolfe SW. Accuracy and reliability of three different techniques for manual goniometry for wrist motion: a cadaveric study. J Hand Surg Am. 2009 Oct;34(8):1422-8. doi: 10.1016/j.jhsa.2009.06.002. Epub 2009 Aug 22.
PMID: 19703734RESULTHamilton GF, McDonald C, Chenier TC. Measurement of grip strength: validity and reliability of the sphygmomanometer and jamar grip dynamometer. J Orthop Sports Phys Ther. 1992;16(5):215-9. doi: 10.2519/jospt.1992.16.5.215.
PMID: 18796752RESULTOxford Grice K, Vogel KA, Le V, Mitchell A, Muniz S, Vollmer MA. Adult norms for a commercially available Nine Hole Peg Test for finger dexterity. Am J Occup Ther. 2003 Sep-Oct;57(5):570-3. doi: 10.5014/ajot.57.5.570.
PMID: 14527120RESULTJensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.
PMID: 14622683RESULTOksuz C, Akel BS, Oskay D, Leblebicioglu G, Hayran KM. Cross-cultural adaptation, validation, and reliability process of the Michigan Hand Outcomes Questionnaire in a Turkish population. J Hand Surg Am. 2011 Mar;36(3):486-92. doi: 10.1016/j.jhsa.2010.11.016. Epub 2011 Feb 4.
PMID: 21295925RESULTDuruoz MT, Poiraudeau S, Fermanian J, Menkes CJ, Amor B, Dougados M, Revel M. Development and validation of a rheumatoid hand functional disability scale that assesses functional handicap. J Rheumatol. 1996 Jul;23(7):1167-72.
PMID: 8823687RESULTRiemann BL, Lephart SM. The sensorimotor system, part I: the physiologic basis of functional joint stability. J Athl Train. 2002 Jan;37(1):71-9.
PMID: 16558670RESULTRoijezon U, Clark NC, Treleaven J. Proprioception in musculoskeletal rehabilitation. Part 1: Basic science and principles of assessment and clinical interventions. Man Ther. 2015 Jun;20(3):368-77. doi: 10.1016/j.math.2015.01.008. Epub 2015 Jan 29.
PMID: 25703454RESULTYoung A, Dixey J, Cox N, Davies P, Devlin J, Emery P, Gallivan S, Gough A, James D, Prouse P, Williams P, Winfield J. How does functional disability in early rheumatoid arthritis (RA) affect patients and their lives? Results of 5 years of follow-up in 732 patients from the Early RA Study (ERAS). Rheumatology (Oxford). 2000 Jun;39(6):603-11. doi: 10.1093/rheumatology/39.6.603.
PMID: 10888704RESULTShauver MJ, Chung KC. The minimal clinically important difference of the Michigan hand outcomes questionnaire. J Hand Surg Am. 2009 Mar;34(3):509-14. doi: 10.1016/j.jhsa.2008.11.001.
PMID: 19258150RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student, Physiotherapy and Rehabilitation
Study Record Dates
First Submitted
August 5, 2026
First Posted
August 10, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
December 28, 2027
Study Completion (Estimated)
December 30, 2027
Last Updated
August 10, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
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.