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Completed

NCT Number: NCT04669704

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental: Tablet application

Other

A protocol of exercises based on the current scientific evidence will be provided through a tablet application. A follow-up of the use of the application will be carried out. A minimum of 4-week home exercise intervention will be performed, which will have to be carried out daily by the patient autonomously at home for at least 5 days per week, starting after baseline measurement.

The exercise program will be individualized according to each pathology.

Comparator: Conventional treatment

Other

In the control condition, participants will receive a home exercise program on paper. The exercise program will be the conventionally prescribed one by the Andalusian Public Health Service. Participants will be told to perform exercises during a minimum of 4 week at home for at least 5 days per week, starting after baseline measurement.

Primary outcomes

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

    Time frame: 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.

  2. 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).

    Time frame: 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.

Secondary outcomes

  1. Dexterity assessed using the Nine Hole Peg Test

    Time frame: Change from baseline Nine Hole Peg Test at one month and three months.

    This test consists of placing nine small cylinders in the nine holes in the base or container of the "Nine Hole Peg Test".

  2. Grip strength assessed using a hydraulic grip dynamometer

    Time frame: Change from baseline Grip strength at one month and three months.

    The Maximun power of the hand muscles used to firmly grasp an object by wrapping the fingers around it, pressing it against the palm, and using the thumb to apply counter-pressure, using a Hydraulic grip dynamometer.

  3. Self-reported pain assessed using a Visual Analog Scale (VAS) of pain.

    Time frame: Change from baseline Visual Analog Scale of Pain at one month and three months.

    Participants report their pain intensity using the 0 to 10 VAS, where 0 refers to "no pain" and 10 refers to "the worst imaginable pain".

  4. Joint position sense test

    Time frame: Change from baseline Joint position sense at one month and three months.

    A test to evaluate the ability to accurately reproduce a specific joint angle without the vision of the joint.

  5. Quality of life is assessed using the Spanish version of the self-completion EQ-5D-5L questionnaire

    Time frame: Change from baseline EQ-5D-5L Questionnaire at one month and three months.

    Brief questionnaire which evaluated health state is in 5 domains: mobility, capacity for self-care, conduct of usual activities, pain or discomfort and anxiety or depression

  6. Wrist flexion and extension range of movement.

    Time frame: Change from baseline wrist flexion and extension range of movement at one month and three months.

    Wrist flexion and extension range of movement assessed using a standard goniometer.

  7. Economic factors relating to cost-utility.

    Time frame: Chage from baseline Economic factors relating to cost-utility at six months.

    Absence due to illness, use of health resources (number of consultations to specialist doctor, physiotherapy occupational therapy sessions, emergency department), time frame in rehabilitation services.

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 17, 2020
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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