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

Carpal Tunnel Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04669704
• Other study ID #: PIN-0143-2017
• Status: Completed
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: January 5, 2022

Study information

• Verified date: January 2022
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 663
• Est. completion date: January 5, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Fracture
• Carpal Tunnel Syndrome
• Distal Radius Fracture
• Dupuytren Contracture
• Dupuytren's Disease
• Fractures, Bone
• Metacarpal Fracture
• Radius Fractures
• Soft Tissue Injuries
• Thumb Osteoarthritis
• Wounds and Injuries

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de la Macarena	Seville	Andalusia
Spain	University of Seville	Seville

Sponsors (2)

Lead Sponsor	Collaborator
University of Seville	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Dexterity assessed using the Nine Hole Peg Test	This test consists of placing nine small cylinders in the nine holes in the base or container of the "Nine Hole Peg Test".	Change from baseline Nine Hole Peg Test at one month and three months.
Secondary	Grip strength assessed using a hydraulic grip dynamometer	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.	Change from baseline Grip strength at one month and three months.
Secondary	Self-reported pain assessed using a Visual Analog Scale (VAS) of pain.	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".	Change from baseline Visual Analog Scale of Pain at one month and three months.
Secondary	Joint position sense test	A test to evaluate the ability to accurately reproduce a specific joint angle without the vision of the joint.	Change from baseline Joint position sense at one month and three months.
Secondary	Quality of life is assessed using the Spanish version of the self-completion EQ-5D-5L questionnaire	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	Change from baseline EQ-5D-5L Questionnaire at one month and three months.
Secondary	Wrist flexion and extension range of movement.	Wrist flexion and extension range of movement assessed using a standard goniometer.	Change from baseline wrist flexion and extension range of movement at one month and three months.
Secondary	Economic factors relating to cost-utility.	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.	Chage from baseline Economic factors relating to cost-utility at six months.