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

NCT ID: NCT04669704

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 663 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2022-01-05

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tablet application

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.

Group Type: EXPERIMENTAL

Experimental: Tablet application

Intervention Type: 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.

Conventional treatment

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.

Group Type: ACTIVE_COMPARATOR

Comparator: Conventional treatment

Intervention Type: 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.

Interventions

Experimental: Tablet application

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.

Intervention Type: OTHER

Comparator: Conventional treatment

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: collaborator

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Maria Dolores Cortes Vega

PhD Professor, University of Seville

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Virgen de la Macarena

Seville, Andalusia, Spain

University of Seville

Seville, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 36758713 (View on PubMed)

Other Identifiers

PIN-0143-2017

Identifier Type: -

Identifier Source: org_study_id