Development and Evaluation of the Effectiveness of the SMART-HAND Protocol for Hand Rehabilitation in Patients With Rheumatoid Arthritis
2026년 8월 13일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
132
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Busra Turk, PT, MSc
- 전화번호: +905448744200
- 이메일: bsrgvn9@gmail.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
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- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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활성 비교기: 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.
|
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.
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활성 비교기: 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.
|
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 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Michigan Hand Outcomes Questionnaire (MHQ)
기간: Baseline, Week 4, Week 8, and Week 12 (Primary endpoint: change from baseline to Week 12)
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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.
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Baseline, Week 4, Week 8, and Week 12 (Primary endpoint: change from baseline to Week 12)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Joint Position Sense (Proprioception)
기간: Baseline, Week 4, Week 8, and Week 12
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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.
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Baseline, Week 4, Week 8, and Week 12
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Nine-Hole Peg Test
기간: 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.
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Baseline, Week 4, Week 8, and Week 12
|
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Duruöz Hand Index
기간: Baseline, Week 4, Week 8, and Week 12
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Hand functional disability will be evaluated using the Duruöz Hand Index.
Higher scores indicate greater disability.
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Baseline, Week 4, Week 8, and Week 12
|
|
Pain Intensity
기간: 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.
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Baseline, Week 4, Week 8, and Week 12
|
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Sensory Threshold
기간: Baseline, Week 4, Week 8, and Week 12
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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
기간: 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.
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Baseline, Week 4, Week 8, and Week 12
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Pinch Strength
기간: Baseline, Week 4, Week 8, and Week 12
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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
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Range of Motion
기간: Baseline, Week 4, Week 8, and Week 12
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Active range of motion of the wrist and finger joints will be measured using standard goniometers and recorded in degrees.
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Baseline, Week 4, Week 8, and Week 12
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2027년 12월 28일
연구 완료 (추정된)
2027년 12월 30일
연구 등록 날짜
최초 제출
2026년 8월 5일
QC 기준을 충족하는 최초 제출
2026년 8월 7일
처음 게시됨 (실제)
2026년 8월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 13일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- IstanbulUC-FTR-BT-02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
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