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

NCT04669704 | Completed DMC

• 1 other identifier: PIN-0143-2017
• Study Type: interventional
• Target: 663
• Locations: 1 country
• Sites: 2

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.

Conditions

Soft Tissue Injuries; Distal Radius Fracture; Metacarpal Fracture; Carpal Fracture; Carpal Tunnel Syndrome; Thumb Osteoarthritis; Dupuytren's Disease

Outcome Measures

Primary Outcomes (2)

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

  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.

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

• 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).

  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.

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

Secondary Outcomes (7)

• Dexterity assessed using the Nine Hole Peg Test

  Change from baseline Nine Hole Peg Test 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.

• 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.

• 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.

Study Arms (2)

Tablet application

EXPERIMENTAL

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.

Other: Experimental: Tablet application

Conventional treatment

ACTIVE COMPARATOR

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.

Other: Comparator: Conventional treatment

Interventions

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.

Tablet application

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.

Conventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Seville: lead
• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: collaborator

Study Sites (2)

Hospital Universitario Virgen de la Macarena

Seville, Andalusia, 41009, Spain

Location

University of Seville

Seville, 41009, Spain

Location

Related Publications (1)

• Suero-Pineda A, Oliva-Pascual-Vaca A, Duran MR, Sanchez-Laulhe PR, Garcia-Frasquet MA, Blanquero J. Effectiveness of a Telerehabilitation Evidence-Based Tablet App for Rehabilitation in Traumatic Bone and Soft Tissue Injuries of the Hand, Wrist, and Fingers. Arch Phys Med Rehabil. 2023 Jun;104(6):932-941. doi: 10.1016/j.apmr.2023.01.016. Epub 2023 Feb 8.

  PMID: 36758713 DERIVED

MeSH Terms

Conditions

Soft Tissue Injuries; Wrist Fractures; Carpal Tunnel Syndrome; Dupuytren Contracture

Condition Hierarchy (Ancestors)

Wounds and Injuries; Wrist Injuries; Arm Injuries; Fractures, Bone; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Professor, University of Seville

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: December 17, 2020
• Study Start: January 20, 2021
• Primary Completion: August 31, 2021
• Study Completion: January 5, 2022
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)