Condition category
Circulatory System
Date applied
15/06/2020
Date assigned
16/06/2020
Last edited
16/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A stroke is a serious life-threatening medical condition that happens when the blood supply to part of the brain is cut off. According to the World Health Organization, cerebrovascular accidents (stroke) are the second leading cause of death and the third leading cause of disability.
One of the most frequent problems after stroke is upper limb (UL) impairments such as muscle weakness, contractures, changes in muscle tone, and other problems related to coordination of arms, hands or fingers. These impairments induce disabilities in common movements such as reaching, picking up or holding objects and difficult activities of daily living (ADLs) such as washing, eating or dressing, their participation in society, and their professional activities. Most of people experiencing this upper limb impairment will still have problems chronically several years after the stroke. Impairment in the upper limbs is one of the most prevalent consequences of stroke. For this reason making rehabilitation is an essential step towards clinical recovery, patient empowerment and improvement of their quality of life.
The greatest functional recovery is achieved in the first weeks and months after the damage. However, patients can improve in tasks, producing a neuronal reorganization even long after the stroke. Despite the latter, survivors continue to experience long-term disability and a decline in their health-related quality of life.
The aim of the project is to increase and deepen the existing knowledge about brain recovery after a stroke and evaluate the effectiveness of virtual reality systems for rehabilitation and improvement of quality of life of the adults stroke.

Who can participate?
Adults diagnosed with stroke (18-85 years old).

What does the study involve?
Rehabilitation programs using virtual reality. The use of games specifically designed for the rehabilitation process.
Virtual reality devices: HandTutor, 3DTutor and Rehametrics.
Participants were randomly assigned to the experimental group (EG) or control group (CG).
EG participants received 15 individual training sessions with virtual reality systems (50 min., five a week), provided by an occupational therapist. Each session is divided into three parts: 5 min. of HandTutor glove placement; 20 min. of HandTutor training; 5 min. of Rehametrics placement (bobath ball, chair, weights, etc.) and 20 min. of Rehametrics training.
The selected exercises are repeated every day. Every day the difficulty increases (number of objects, speed, etc.).
The control group was not treated with virtual reality. They were only doing motor training in physical and occupational therapy.

What are the possible benefits and risks of participating?
The possible benefits of using virtual reality technology in rehabilitation processes with stroke adults include improvement of upper limb mobility, the balance and walking and improvement in the performance of daily life activities.
The possible adverse effects include fatigue, muscle pain and headaches.

Where is the study run from?
The study has been designed from the University of Castilla La Mancha (Spain) and rehabilitation sessions with technology based on virtual reality are being developed in the University General Hospital of Talavera de la Reina.

When is the study starting and how long is it expected to run for?
April 2019 to April 2021

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
1. Marta Rodríguez-Hernández
Marta.RHernandez@uclm.es
2. Dra. Begoña Polonio-López
Begona.Polonio@uclm.es

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marta Rodríguez-Hernández

ORCID ID

https://orcid.org/0000-0003-2182-8870

Contact details

University of Castile-La Mancha
Faculty of Science Health
Avenida Real Fábrica de Sedas
s/n
Talavera de la Reina
45600
Spain
+34 627832682
Marta.RHernandez@uclm.es

Additional identifiers

EudraCT number

No

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

TECHNOREHAB: randomized clinical trial for the technological rehabilitation of adults with stroke

Acronym

TECHNOREHAB

Study hypothesis

1. The use of virtual reality devices improves the upper limb mobility in patients post-ictus
2. The use of virtual reality devices improves the balance and walking in patients post-ictus
3. The use of virtual reality exercises increases functional independence in patients post-ictus
4. Participation in a virtual reality exercise program produces changes sensation of well-being and quality of life

Ethics approval

Approved 17/04/2018, Clinical Research Ethical Committee of the Talavera de la Reina Integrated Management Area (CEIC del AGI de Talavera de la Reina, Hospital Nuestra Señora del Prado. Ctra. Nacional V, km. 114, 45600, Talavera de la Reina (Toledo), Spain; +34 (0)925 80 36 00 Ext. 86.316; varroyo@sescam.org), ref: 12/2018

Study design

Longitudinal prospective randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use conact details to request a participant information sheet.

Condition

Motor injuries and functional dependence in adults with stroke

Intervention

Rehabilitation programs using virtual reality. The use of games specifically designed for the rehabilitation process.
Virtual reality devices: HandTutor, 3DTutor and Rehametrics.
The assignment to each of the groups was parallel. Participants were randomly assigned to the experimental group (EG) or control group (CG), with an allocation ratio of 1:1.
Randomisation process: sealed envelope.
Blinding of trial participants and therapist was not possible.

Experimental group: participants received 15 individual training sessions with virtual reality systems (50 min., five a week), provided by an occupational therapy and training of motricity and fuerza with physical and occupational therapist of the hospital. Each session is divided into three parts: 5 min. of HandTutor glove placement; 20 min. of HandTutor training; 5 min. of Rehametrics placement (bobath ball, chair, weights, etc.) and 20 min. of Rehametrics training.
The selected exercises are repeated every day. Every day the difficulty increases (number of objects, speed, etc.).

Control group: the control group was not treated with virtual reality. They were only doing motor training in physical and occupational therapy.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. The impact of stroke on daily life is measured using SIS 3.0 scale at baseline, the end of study (15 sessions), 3 and 6 months
2. Walking capacity and balance is measured using Tinetti Test at baseline, the end of study (15 sessions), 3 and 6 months
3. The motor function of the upper limb is measured using Ara-T and Fugl-Meyer at baseline, the end of study (15 sessions), 3 and 6 months
4. Perceived quality of life is measured using EuroQool-5L Test at baseline, the end of study (15 sessions), 3 and 6 months

Secondary outcome measures

1. Resistance to movement in the paretic upper limb is measured by the Modified Ashworth Scale at baseline, the end of study (15 sessions), 3 and 6 months
2. User satisfaction with the device is measured with the Quebec Scale at the end of study (15 sessions)

Overall trial start date

30/01/2018

Overall trial end date

17/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age between 18 and 85 years old
2. Diagnosed stroke
3. Difficulties motor skills of the upper limb
4. Dependence in daily life activities
5. Time of evolution since diagnosis: maximum 6 months
6. No other disabling pathology prior to the injury
7. Not having a life expectancy of less than 6 months
8. Acceptance and signature of the informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 participants in each group.

Participant exclusion criteria

1. Presence of other neurological disorders
2. Severe heminegligency
3. Psychiatric disorders that hinder participation
4. Signature of revocation of consent

Recruitment start date

01/04/2019

Recruitment end date

01/04/2021

Locations

Countries of recruitment

Spain

Trial participating centre

University of Castilla La Mancha
Faculty of Science Health Avenida Real Fábrica de Sedas s/n
Talavera De La Reina
45600
Spain

Trial participating centre

University General Hospital
Carretera de Madrid Avenida de Extremadura, KM 114.
Talavera de la Reina
45600
Spain

Sponsor information

Organisation

University of Castile-La Mancha

Sponsor details

Faculty of Science Health
Avenida Real Fábrica de Sedas
s/n
Talavera de la Reina
45600
Spain
+34 925268800 Ext. 5623
Begona.Polonio@uclm.es

Sponsor type

University/education

Website

https://www.uclm.es/toledo/facsalud

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement.
The datasets generated during and/or analysed during the current study are/will be available upon request from Marta Rodríguez-Hernández (Marta.RHernandez@uclm.es).

Intention to publish date

01/09/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/06/2020: Trial’s existence confirmed by Clinical Research Ethical Committee of the Talavera de la Reina Integrated Management Area.