Clinical trial NCT04669704: Effectiveness of a Tele-Rehabilitation Evidence-based Tablet App for Rehabilitation in Traumatic Bone and Soft Injuries of the Hand, Wrist and Fingers.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Injuries
Distal Radius Fracture
Metacarpal Fracture
Carpal Fracture
Carpal Tunnel Syndrome
Thumb Osteoarthritis
Dupuytren's Disease
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
First posted: 2020-12-17
Enrollment: 663
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Self-reported functional ability using the validated Spanish version of the QuickDASH in patients with hand conditions.
timeFrame: Change from Baseline QuickDASH at one month, three months and six months.
measure: 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).
timeFrame: Change from baseline PRWE at one month, three months and six months.
Secondary outcomes:
measure: Dexterity assessed using the Nine Hole Peg Test
timeFrame: Change from baseline Nine Hole Peg Test at one month and three months.
measure: Grip strength assessed using a hydraulic grip dynamometer
timeFrame: Change from baseline Grip strength at one month and three months.
measure: Self-reported pain assessed using a Visual Analog Scale (VAS) of pain.
timeFrame: Change from baseline Visual Analog Scale of Pain at one month and three months.
measure: Joint position sense test
timeFrame: Change from baseline Joint position sense at one month and three months.
measure: Quality of life is assessed using the Spanish version of the self-completion EQ-5D-5L questionnaire
timeFrame: Change from baseline EQ-5D-5L Questionnaire at one month and three months.
measure: Wrist flexion and extension range of movement.
timeFrame: Change from baseline wrist flexion and extension range of movement at one month and three months.
measure: Economic factors relating to cost-utility.
timeFrame: Chage from baseline Economic factors relating to cost-utility at six months.
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Hospital Universitario Virgen de la Macarena
state: Andalusia
city: Seville
country: Spain
facility: University of Seville
Study officials:
References: