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

Primary Purpose

Soft Tissue Injuries, Distal Radius Fracture, Metacarpal Fracture

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental: Tablet application
Comparator: Conventional treatment
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Virgen de la Macarena
  • University of Seville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tablet application

Conventional treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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".
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.
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".
Joint position sense test
A test to evaluate the ability to accurately reproduce a specific joint angle without the vision of the joint.
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
Wrist flexion and extension range of movement.
Wrist flexion and extension range of movement assessed using a standard goniometer.
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.

Full Information

First Posted
November 22, 2020
Last Updated
January 11, 2022
Sponsor
University of Seville
Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT04669704
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
January 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Injuries, Distal Radius Fracture, Metacarpal Fracture, Carpal Fracture, Carpal Tunnel Syndrome, Thumb Osteoarthritis, Dupuytren's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
663 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tablet application
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Experimental: Tablet application
Intervention Description
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
Intervention Name(s)
Comparator: Conventional treatment
Intervention Description
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 Outcome Measure Information:
Title
Self-reported functional ability using the validated Spanish version of the QuickDASH in patients with hand conditions.
Description
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.
Time Frame
Change from Baseline QuickDASH at one month, three months and six months.
Title
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).
Description
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.
Time Frame
Change from baseline PRWE at one month, three months and six months.
Secondary Outcome Measure Information:
Title
Dexterity assessed using the Nine Hole Peg Test
Description
This test consists of placing nine small cylinders in the nine holes in the base or container of the "Nine Hole Peg Test".
Time Frame
Change from baseline Nine Hole Peg Test at one month and three months.
Title
Grip strength assessed using a hydraulic grip dynamometer
Description
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.
Time Frame
Change from baseline Grip strength at one month and three months.
Title
Self-reported pain assessed using a Visual Analog Scale (VAS) of pain.
Description
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".
Time Frame
Change from baseline Visual Analog Scale of Pain at one month and three months.
Title
Joint position sense test
Description
A test to evaluate the ability to accurately reproduce a specific joint angle without the vision of the joint.
Time Frame
Change from baseline Joint position sense at one month and three months.
Title
Quality of life is assessed using the Spanish version of the self-completion EQ-5D-5L questionnaire
Description
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
Time Frame
Change from baseline EQ-5D-5L Questionnaire at one month and three months.
Title
Wrist flexion and extension range of movement.
Description
Wrist flexion and extension range of movement assessed using a standard goniometer.
Time Frame
Change from baseline wrist flexion and extension range of movement at one month and three months.
Title
Economic factors relating to cost-utility.
Description
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.
Time Frame
Chage from baseline Economic factors relating to cost-utility at six months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital Universitario Virgen de la Macarena
City
Seville
State/Province
Andalusia
ZIP/Postal Code
41009
Country
Spain
Facility Name
University of Seville
City
Seville
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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