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临床试验/NCT04669704
NCT04669704已完成不适用

Clinical and Economic Effectiveness of a Tele-rehabilitation Evidence-based Tablet Application for Rehabilitation in Traumatic Bone and Soft Injuries of the Hand, Wrist and Fingers.

University of Seville4 个研究点 分布在 1 个国家目标入组 663 人开始时间: 2021年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
663
试验地点
4
主要终点
Wrist pain and disability in activities of daily living is assessed using the Spanish version of the 15-item questionnaire Patient Rated Wrist Evaluation (PRWE).

研究概览

简要总结

Trauma and soft injuries of the wrist, hand and fingers have a high incidence, and large social and healthcare costs are generated, mainly due to productivity loss. Therapeutic exercises must be part of the treatment and in the last 10 years the scientific literature highlights the need for the inclusion of the sensorimotor system in both surgical and rehabilitative approaches. Current methods as leaflets or videos lacks of adherence control, evolution control and knowledge of how the patient do the exercises which compromise the expected results. Touch-screens of Tablet devices have showed a large potential to cover these needs and for the retraining of sensorimotor system. ReHand is a Tablet digital tool (Android and iOS) to prescribe and monitor exercise programs based on sensorimotor approach and developed under the guidelines of various healthcare professionals (hand surgeons, physiotherapists, rehabilitators and occupational therapists) to implement home exercise programs and monitor patients. Subjects are selected by emergency, hand surgery, rehabilitation and physiotherapy services of six hospitals from Andalusian Public Health Service through consecutive sampling. Concretely, patients over 18 years of age with trauma and soft injuries of the wrist, hand and fingers, no more than 10 days after surgery or removal of immobilization. Experimental group will receive access to ReHand app to perform a monitored home exercises program. Control group will receive the conventional method employed: a home exercise program in paper with recommendations. Clinical variables will be assessed at baseline before group allocation, 4 weeks, 3 months and 6 months. At the end of the study, cost-utility variables will be analyzed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age over 18
  • Patients with trauma or soft tissue injuries of the wrist, hand and fingers. Dupuytren, carpal tunnel syndrome, rizarthrosis, distal radius fracture, carpal fracture or metacarpal fracture.

排除标准

  • Neurological pathology that affects the upper limb.
  • Non-cooperative.
  • Psychiatric illness.

结局指标

主要结局

Wrist pain and disability in activities of daily living is assessed using the Spanish version of the 15-item questionnaire Patient Rated Wrist Evaluation (PRWE).

时间窗: Change from baseline PRWE at one month, three months and six months.

The PRWE comprises a 5-item pain subscale and a 10-item function subscale. The final score is between 0 - 100 points with higher scores indicating more disability.

Self-reported functional ability using the validated Spanish version of the QuickDASH in patients with hand conditions.

时间窗: Change from Baseline QuickDASH at one month, three months and six months.

The shortened form of the DASH questionnaire (Disabilities of the Arm, Shoulder and Hand questionnaire) is an 11-item questionnaire that measures patient's ability to complete tasks, absorb forces, and severity of symptoms.

次要结局

  • Self-reported pain assessed using a Visual Analog Scale (VAS) of pain.(Change from baseline Visual Analog Scale of Pain at one month and three months.)
  • Economic factors relating to cost-utility.(Chage from baseline Economic factors relating to cost-utility at six months.)
  • Dexterity assessed using the Nine Hole Peg Test(Change from baseline Nine Hole Peg Test at one month and three months.)
  • Wrist flexion and extension range of movement.(Change from baseline wrist flexion and extension range of movement at one month and three months.)
  • Grip strength assessed using a hydraulic grip dynamometer(Change from baseline Grip strength at one month and three months.)
  • Joint position sense test(Change from baseline Joint position sense at one month and three months.)
  • Quality of life is assessed using the Spanish version of the self-completion EQ-5D-5L questionnaire(Change from baseline EQ-5D-5L Questionnaire at one month and three months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Dolores Cortes Vega

PhD Professor, University of Seville

University of Seville

研究点 (4)

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