Development and Evaluation of the Effectiveness of the SMART-HAND Protocol for Hand Rehabilitation in Patients With Rheumatoid Arthritis
13 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
132
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Busra Turk, PT, MSc
- Numéro de téléphone: +905448744200
- E-mail: bsrgvn9@gmail.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Comparateur actif: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Michigan Hand Outcomes Questionnaire (MHQ)
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Joint Position Sense (Proprioception)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
28 décembre 2027
Achèvement de l'étude (Estimé)
30 décembre 2027
Dates d'inscription aux études
Première soumission
5 août 2026
Première soumission répondant aux critères de contrôle qualité
7 août 2026
Première publication (Réel)
10 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IstanbulUC-FTR-BT-02
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .