Gymnasium for Robotic Rehabilitation (Gimnasio de Rehabilitación Robótica)
| ISRCTN | ISRCTN98578807 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98578807 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/07/2015
- Registration date
- 10/08/2015
- Last edited
- 19/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Stroke is a condition that affects about 15 million people every year. It is caused by an interruption of the blood supply to the brain caused by rupture of a blood vessel or its obstruction. Today, stroke is one of the main causes of disability in the developing and the developed world. It is believed that intensive long-term therapy can diminish the level of disability, but for many people, especially in developing countries, treatment is not affordable. The aim of this study is to find if a gymnasium for robotic rehabilitation can provide a cost and labor effective alternative therapy for stroke patients.
Who can participate?
Patients between 21 and 75 years old, diagnosed with hemiplegia (paralysis of one side of the body) from a stroke that occurred no less than 6 months before the study.
What does the study involve?
Participants will be randomly assigned to one of two groups. One of the groups will receive 24 sessions of traditional therapy, which consists of physical and occupational therapy according with the recommendations of the physician. The other group will receive the same 24 sessions of therapy in the robotic gym, consisting of several workstations based on game therapies and occupational therapy. Each station is configured specifically for the needs of each person and changes depending the person’s progress.
What are the possible benefits and risks of participating?
Possible benefits for the participant include improvement in arm and/or leg function, but this is not guaranteed. Risks associated with the participation in this study include frustration, fatigue, discomfort, soreness, swelling and skin irritation.
Where is the study run from?
Centro de Rehabilitación y Educación Especial (CREE) (Mexico).
When is the study starting and how long is it expected to run for?
From November 2010 to February 2014.
Who is funding the study?
Consejo Nacional de Ciencia y Tecnología (Mexico).
Who is the main contact?
Dr Michelle Johnson
johnmic@mail.med.upenn.edu
Contact information
Scientific
University of Pennsylvania
1800 Lombard Street
Philadelphia
19146
United States of America
| Phone | +1 (0)215 893 2665 |
|---|---|
| johnmic@mail.med.upenn.edu |
Study information
| Study design | Single-centre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Gymnasium for Robotic Rehabilitation (Gimnasio de Rehabilitación Robótica): a randomized controlled trial |
| Study acronym | Robot Gym |
| Study objectives | The hypothesis of the protocol is that the "Gymnasium for Robotic Rehabilitation" (Robot Gym) is capable to provide a low-cost and labor efficient alternative to post stroke rehabilitation. All this while being more or as efficient as traditional therapies in the State of Chihuahua, Mexico. |
| Ethics approval(s) | 1. Marquette University Institutional Review Board, 04/03/2011 2. Comité del Centro de Rehabilitación y Educación Especial Turno Vespertino (Committee of the Center for Rehabilitation and Special Education Afternoon Shift), 23/09/2011 |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | Patients were randomly allocated to receive either traditional or Robot Gym rehabilitation therapy. The robot Gym therapy consist of six stations of computer and motor-assisted devices which aid in the cognitive enhancement and motor rehabilitation of upper and lower extremities. The first station is formed by a low cost system for arm rehabilitation called Theradrive; this device allows patients to realize therapy while playing commercial videogames with a Logitech wheel. Second and third stations house the Bioness devices (NESS H200 and L300), which provides functional electrical stimulation to hand and foot, respectively. The MOTOMed devices are on the fourth and fifth stations to help motor rehabilitation on the upper and lower limbs through a series of games played by doing movements similar to bicycling. The last station is formed by the Capitains Log Brain-Trainer, which is a commercial cognitive rehabilitation therapy system to improve neuroplasticity. The traditional therapy is formed by the standard physical therapy, which includes physical and occupational therapy, personalized for each patient. This type of therapy seeks to improve the range of motion and muscle strength, as well as improve the performance of activities of daily living. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | All selected patients will receive the following tests to measure our primary outcomes one week before the start of the 24 therapy sessions and one week after the end of the 24 sessions: 1. Kinetic and kinematic of lower and upper extremity data using the motion analysis lab 2. Motivational survey 3. Fugl Meyer for upper and lower extremities 4. Functional Test 5. Box and blocks 6. Timed Get up and Go 7. Six Minutes Walk 8. Ten Meters Walk |
| Secondary outcome measures | 1. Minimental Test at the initial consult with the physiatrist, approximately 2 weeks before the 24 sessions of therapy and during the final consult 2 weeks after the end of the intervention. 3. Geriatric Depression Scale at the initial consult with the physiatrist, approximately 2 weeks before the 24 sessions of therapy and during the final consult 2 weeks after the end of the intervention. 3. Pain and exercise survey (using visual analogue scale) are performed every third session starting from session one through the end of the sessions 4. Motor Activity Log applied one week before the beginning of therapy and one week after the end of the 24th session 5. Visual Neglect Test (Albert's test) at the initial consult with the physiatrist, approximately 2 weeks before the 24 sessions of therapy and during the final consult 2 weeks after the end of the intervention. |
| Overall study start date | 01/11/2010 |
| Completion date | 12/02/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 24 subjects was the target population for the grant but permission to IRB was to recruit 25% more of that number to allow for patient drop out. The purpose is to have at least 6 subjects in each group to allow for statistical comparisons |
| Key inclusion criteria | 1. Patients who were clinically diagnosed with hemiplegia from stroke occurred no less than 6 months prior to the study 2. Medically stable 3. Between 21 and 75 years old 4. The subject must have the left side affected 5. The subject must have the ability to sit for 60 minutes and to stand assisted or unassisted for 30-40 minutes 6. They must not be more than mildly depressed and moderately cognitively disabled 7. Must have residual motion in shoulder and elbow, and residual movement in leg flexion, extension and hip adduction (Brunnstrom scale ranging from 2 to 5, Ashworth scale over 4 and Manual Muscular Test >1 and <3) |
| Key exclusion criteria | 1. Psychiatric disorders 2. Excessive spasticity in upper or lower extremities that prevent engaging in therapy activities 3. Excessive joint pain 4. Pregnant or breastfeeding 5. More than a score of four in Ashworth test 6. Unwillingness to participate in the protocol |
| Date of first enrolment | 01/01/2012 |
| Date of final enrolment | 30/09/2013 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Santa Rosa
Chihuahua
31060
Mexico
Sponsor information
University/education
735 N. 17th Street, ASF 105
Milwaukee
53233
United States of America
| Phone | +1 (0)414 288 0697 |
|---|---|
| amanda.ahrndt@marquette.edu | |
| Website | http://www.marquette.edu/orc/irb/ |
"ROR" |
https://ror.org/04gr4te78 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Consejo Nacional de Ciencia y Tecnología, National Council of Humanities, Sciences and Technologies, Mexican National Council of Science and Technology, National Council for Science and Technology (CONACyT), National Council of Science and Technology, Mexico, Conahcyt
- Location
- Mexico
Results and Publications
| Intention to publish date | 01/05/2011 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results will be published and disseminated in international conferences and scientific journals. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/09/2016 | Yes | No |
Editorial Notes
19/09/2016: Publication reference added.
