Soft Tissue InjuriesNCT04669704
Effectiveness of a Tele-Rehabilitation Evidence-based Tablet App for Rehabilitation in Traumatic Bone and Soft Injuries of the Hand, Wrist and Fingers.
A study testing Experimental: Tablet application and Comparator: Conventional treatment in people with Soft Tissue Injuries and Distal Radius Fracture, run by University of Seville at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Injuries, Distal Radius Fracture, Metacarpal Fracture
- What is being tested?
- Experimental: Tablet application and Comparator: Conventional treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 663 participants
- Where
- 2 sitesSpain
- Study dates
- 20 Jan 2021to 5 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Neurological pathology that affects the upper limb.
- Non-cooperative.
- Psychiatric illness.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Virgen de la Macarena
Seville, Andalusia, 41009
University of Seville
Seville, 41009
About this study
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.
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
- Being tested
- Experimental: Tablet application, Comparator: Conventional treatment
- Medical subject headings
- Soft Tissue Injuries, Wrist Fractures, Carpal Tunnel Syndrome, Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Tablet applicationOther
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 treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Comparator: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline PRWE at one month, three months and six months.
Secondary outcomes (7)
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".
Measured: Change from baseline Nine Hole Peg Test at one month and three months.
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.
Measured: Change from baseline Grip strength at one month and three months.
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".
Measured: Change from baseline Visual Analog Scale of Pain at one month and three months.
Joint position sense test
A test to evaluate the ability to accurately reproduce a specific joint angle without the vision of the joint.
Measured: 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
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
Measured: Change from baseline EQ-5D-5L Questionnaire at one month and three months.
Wrist flexion and extension range of movement.
Wrist flexion and extension range of movement assessed using a standard goniometer.
Measured: Change from baseline wrist flexion and extension range of movement at one month and three months.
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.
Measured: Chage from baseline Economic factors relating to cost-utility at six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start20 Jan 2021
- Primary completion31 Aug 2021
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 663 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Responsible party
- Principal investigator, Maria Dolores Cortes Vega, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669704
- Sponsor's protocol ID
- PIN-0143-2017
- Status last verified
- Jan 2022
- First submitted
- 22 Nov 2020
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36758713
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04669704
- Acronym / sponsor ID
- PIN-0143-2017
- Conditions
- Soft Tissue Injuries, Distal Radius Fracture, Metacarpal Fracture, Carpal Fracture, Carpal Tunnel Syndrome, Thumb Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 663 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet application | Experimental | Other: Experimental: Tablet applicationA 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 | Active comparator | Other: Comparator: Conventional treatmentIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Neurological pathology that affects the upper limb.
- Non-cooperative.
- Psychiatric illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Tablet applicationA 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 | Tablet application |
| Comparator: Conventional treatmentIn 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 | Conventional treatment |
Primary outcome
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.
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.
7 secondary outcomes
Dexterity assessed using the Nine Hole Peg Test
Time frame: Change from baseline Nine Hole Peg Test at one month and three months.
Grip strength assessed using a hydraulic grip dynamometer
Time frame: Change from baseline Grip strength at one month and three months.
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.
Joint position sense test
Time frame: 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
Time frame: Change from baseline EQ-5D-5L Questionnaire at one month and three months.
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.
Economic factors relating to cost-utility.
Time frame: Chage from baseline Economic factors relating to cost-utility at six months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Derived from this study: PubMed 36758713Suero-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Tablet application and Comparator: Conventional treatment in people with Soft Tissue Injuries and Distal Radius Fracture, run by University of Seville at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04669704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.