Development and Evaluation of the Effectiveness of the SMART-HAND Protocol for Hand Rehabilitation in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 132
- 主要终点
- Michigan Hand Outcomes Questionnaire (MHQ)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: SMART-HAND Protocol (Behavioral)
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.
干预措施: Conventional Hand Rehabilitation (Behavioral)
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.
干预措施: Joint Protection and Ergonomic Education (Behavioral)
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.
干预措施: SMART-HAND Protocol (Behavioral)
结局指标
主要结局
Michigan Hand Outcomes Questionnaire (MHQ)
时间窗: 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.
次要结局
- 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)
- Grip Strength(Baseline, Week 4, Week 8, and Week 12)
- Pinch Strength(Baseline, Week 4, Week 8, and Week 12)
- Range of Motion(Baseline, Week 4, Week 8, and Week 12)
研究者
Busra Turk
PhD Student, Physiotherapy and Rehabilitation
Istanbul University - Cerrahpasa