Transcranial direct current stimulation (tDCS) combined with robotic rehabilitation for upper limbs in stroke
| ISRCTN | ISRCTN29077878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29077878 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of Castile-La Mancha |
| Funder | Investigator initiated and funded |
- Submission date
- 07/10/2021
- Registration date
- 22/03/2022
- Last edited
- 03/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
A stroke is a serious life-threatening medical condition that occurs 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 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, rehabilitation is an essential step towards clinical recovery, patient empowerment, and improvement of their quality of life.
Rehabilitation-based robotics have shown moderate efficacy for rehabilitating upper limbs.
Noninvasive brain stimulation is a method for modulating electrical activity of the brain. Specifically, transcranial direct current stimulation (tDCS) is useful in the rehabilitation process.
The aim of the project is to evaluate the efficacy of combined tDCS with robotic training for motor recovery of the upper limb after stroke.
Who can participate?
Adults diagnosed with stroke (18-85 years old).
What does the study involve?
Rehabilitation programs using tDCS combined with robotic training.
Participants were randomly assigned to the experimental group (EG) or control group (CG).
EG participants received 20 individual training sessions with tDCS and robotic training. Each session lasted 20-30 minutes.
CG is a similar protocol but they received sham stimulation, for only 30 seconds.
What are the possible benefits and risks of participating?
The possible benefits of using tDCS combined with robotic treatment in rehabilitation processes with stroke adults include improvement of upper limb mobility and function 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 was designed at the University of Castilla La Mancha (Spain) and rehabilitation sessions with technology based on virtual reality were developed in the Neuron Center of Madrid (Spain).
When is the study starting and how long is it expected to run for?
July 2020 to August 2022.
Who is funding the study?
Investigator initiated and funded.
Who is the main contact?
1. Juan Bernal Jiménez, Juanjose.Bernal@uclm.es (primary contact)
2. Dra Begoña Polonio-López, Begona.Polonio@uclm.es (primary contact)
3. Dra Laura Mordillo, Laura.Mordillo@uclm.es
Contact information
Principal investigator
University of Castile-La Mancha
Faculty of Science Health
Avenida Real Fábrica de Sedas
s/n
Talavera de la Reina
45600
Spain
 ORCID ID |
0000-0001-7031-1611 |
|---|---|
| Phone | +34 678158045 |
| juanjose.bernal@uclm.es |
Principal investigator
Faculty of Health Sciences
University of Castilla-La Mancha
Av. Real Fábrica de Sedas s/n
Talavera de la Reina
45600
Spain
| ORCID ID |
0000-0003-2922-7519 |
|---|---|
| Phone | +34682247830 |
| Begona.Polonio@uclm.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Transversal prospective randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 40522 PIS.pdf |
| Scientific title | Randomized clinical trial of tDCS combined with robotic rehabilitation for upper limbs in stroke |
| Study objectives | Robotic therapy combined with tDCS enhances motor recovery in stroke patients |
| Ethics approval(s) | Approved 17/07/2020, 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 |
| Health condition(s) or problem(s) studied | Motor injuries of the upper limb and functional dependence in adults with stroke |
| Intervention | Rehabilitation programs using robotic treatment combined with tDCS. The robot device is Amadeo, Tyromotion. The assignment to each of the groups was parallel. Participants were randomly assigned to the experimental group (EG) or control group (CG). Participants and therapists were blinded. Experimental group: participants received 20 sessions of robotic combined with tDCS. Robotic training lasted 20-30 minutes and it was specific finger training. tDCS was applied online with robotic treatment. tDCS lasted 20 minutes. Control group: participants received a similar robotic protocol but tDCS lasted 30 seconds, and it was a sham intervention. The rest of the protocol was the same as in the experimental group. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. The impact of stroke on daily life was measured using the Functional Independence Measure at baseline, at the end of the study (20 sessions), and at 3 months. |
| Key secondary outcome measure(s) |
1. Muscle tone assessment using modified Ashworth Test at baseline, the end of study (20 sessions), and 3 months. |
| Completion date | 09/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 21 |
| Total final enrolment | 21 |
| Key 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. No other disabling pathology prior to the injury 6. Acceptance and signature of the informed consent |
| Key exclusion criteria | 1. Cognitive impairment (<24 in Mini-mental state exam) 2. Severe Aphasia 3. Upper limb fractures 4. Unresolved vascular problem 5. tDCS contraindications such as epilepsy 6. No signing informed consent |
| Date of first enrolment | 28/03/2022 |
| Date of final enrolment | 04/04/2022 |
Locations
Countries of recruitment
- Spain
Study participating centres
Avenida Real Fábrica de Sedas s/n
Talavera de la Reina
45600
Spain
Madrid
28003
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Juan Bernal Jiménez (JuanJose.Bernal@uclm.es). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/02/2024 | 03/09/2024 | Yes | No | |
| Participant information sheet | in Spanish | 07/10/2021 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 40522 PIS.pdf
- in Spanish
Editorial Notes
03/09/2024: Publication reference added.
04/08/2022: The intention to publish date has been changed from 01/09/2022 to 01/11/2022.
17/06/2022: The following changes have been made:
1. The recruitment start date has been changed from 01/09/2020 to 28/03/2022.
2. The recruitment end date has been changed from 01/04/2022 to 04/04/2022.
3. The overall trial end date has been changed from 01/07/2022 to 09/08/2022 and the plain English summary has been updated to reflect this change.
07/06/2022: A study contact has been added and the plain English summary has been updated accordingly.
25/03/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/10/2020 to 01/04/2022.
2. The overall trial end date has been changed from 01/12/2021 to 01/07/2022 and the plain English summary has been updated to reflect this change.
07/10/2021: Trial's existence confirmed by Clinical Research Ethical Committee of the Talavera de la Reina Integrated Management Area.
