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Rheumatoid ArthritisNCT07754552

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

A study testing SMART-HAND Protocol, Conventional Hand Rehabilitation and Joint Protection and Ergonomic Education in people with Rheumatoid Arthritis and Rheumatoid Arthritis (RA, run by Istanbul University - Cerrahpasa.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SMART-HAND Protocol, Conventional Hand Rehabilitation and Joint Protection and Ergonomic Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 30 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Busra Turk, PT, MSc contact

+905448744200

bsrgvn9@gmail.com

About this study

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.

Being tested
SMART-HAND Protocol, Conventional Hand Rehabilitation, Joint Protection and Ergonomic Education
Keywords
Rheumatoid Arthritis, Hand Rehabilitation, Hand Function, Proprioception, Neuromuscular Control, Grip Strength, Joint Stability
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SMART-HAND ProtocolBehavioural

    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 RehabilitationBehavioural

    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 EducationBehavioural

    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 groups in NCT07754552
Study groupRoleWhat they receive
SMART-HAND ProtocolExperimentalParticipants 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.
Receives: Behavioral: SMART-HAND Protocol
Conventional Hand Rehabilitation GroupActive 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.
Receives: Behavioral: Conventional Hand Rehabilitation
Usual Care + Education GroupActive 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.
Receives: Behavioral: SMART-HAND Protocol; Behavioral: Joint Protection and Ergonomic Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (8)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline, Week 4, Week 8, and Week 12

  5. Sensory Threshold

    Cutaneous sensory threshold will be evaluated using Semmes-Weinstein monofilaments. The thinnest monofilament perceived by the participant will be recorded.

    Measured: Baseline, Week 4, Week 8, and Week 12

  6. Grip Strength

    Maximum hand grip strength will be measured using a Jamar dynamometer. The average of three maximal contractions will be recorded in kilograms.

    Measured: Baseline, Week 4, Week 8, and Week 12

  7. Pinch Strength

    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.

    Measured: Baseline, Week 4, Week 8, and Week 12

  8. Range of Motion

    Active range of motion of the wrist and finger joints will be measured using standard goniometers and recorded in degrees.

    Measured: Baseline, Week 4, Week 8, and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion28 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to one of three parallel groups: (1) the SMART-HAND protocol group, (2) the conventional hand rehabilitation group, or (3) the control group. The intervention will be administered for 12 weeks, and outcome measures will be assessed at baseline and at the end of the intervention.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07754552
Sponsor's protocol ID
IstanbulUC-FTR-BT-02
Status last verified
Aug 2026
First submitted
5 Aug 2026
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 38827650
  • Jerosch-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.

    PubMed 15862365
  • Hillier 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.

    PubMed 25712470
  • Lewis 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.

    PubMed 20825126
  • Carter 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.

    PubMed 19703734
  • Hamilton 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.

    PubMed 18796752
  • Oxford 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.

    PubMed 14527120
  • Jensen 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.

    PubMed 14622683
  • Oksuz 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.

    PubMed 21295925
  • Duruoz 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.

    PubMed 8823687
  • Riemann BL, Lephart SM. The sensorimotor system, part I: the physiologic basis of functional joint stability. J Athl Train. 2002 Jan;37(1):71-9.

    PubMed 16558670
  • Roijezon 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.

    PubMed 25703454
  • Young 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.

    PubMed 10888704
  • Shauver 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.

    PubMed 19258150

Questions about this trial

What is this clinical trial studying?

A study testing SMART-HAND Protocol, Conventional Hand Rehabilitation and Joint Protection and Ergonomic Education in people with Rheumatoid Arthritis and Rheumatoid Arthritis (RA, run by Istanbul University - Cerrahpasa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Busra Turk, PT, MSc (+905448744200, bsrgvn9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07754552, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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