Treadmill in stroke rehabilitation
| ISRCTN | ISRCTN17138124 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17138124 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Akademii Wychowania Fizycznego im. Jerzego Kukuczki w Katowicach |
| Funders | The Medical and Rehabilitation Center ''Solanki'' in Inowroclaw, Poland, European Regional Development Fund for the Kuyavian-Pomeranian Voivodeship, Poland No. RPKK.01.02.01-04-0016/18. |
- Submission date
- 14/02/2022
- Registration date
- 03/03/2022
- Last edited
- 03/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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.
Strokes are a global burden. People of all ages suffer from strokes, including relatively young and professionally active people. Post-stroke rehabilitation is multi-directional and long-lasting. There is still a need to search for new methods of rehabilitation of post-stroke therapy that will ensure effective and quick recovery of patients. Thanks to the development of medicine, physiotherapy and biomedical engineering, modern technologies are created and used in the process of post-stroke rehabilitation. However, there is a need for research confirming the effectiveness of therapy with the use of these technologies, as well as the need to improve the methodology of conducting therapy with the use of these devices.
These novel technologies include i.a. stationary gait rehabilitation robots, exoskeletons, treadmills equipped with virtual reality and feedback or treadmills with other various modifications, e.g. systems that unbalance the patient while walking.
The general aim of the study is to obtain knowledge on whether exercise using modern technologies such as the use of a treadmill equipped with virtual reality, biofeedback and balance perturbation systems can contribute to the improvement in stroke rehabilitation.
Who can participate?
Chronic post-stroke survivors over 18 years of age
What does the study involve?
50 patients, who will be randomly assigned to one of the 2 following groups:
1) The experimental group (EG), in which 25 patients will receive treadmill training with controlled body balance perturbations (Balance Tutor; MediTouch, Israel), 6 days a week (Monday to Saturday) for 30 minutes a day, for 3 weeks.
2) The control group (CG), in which 25 patients will receive traditional ground gait training for 30 minutes a day for 3 weeks, 6 days a week (Monday to Saturday).
In addition, all patients in both groups will be subjected to typical post-stroke rehabilitation for 2.5 hours a day, 6 days a week (Monday-Saturday), based on the principles of best clinical practices. The aim of the exercises will be to normalize muscle tone and improve movement patterns.
What are the possible benefits and risks of participating?
It is presumed that the treatment will contribute to the improvement of static and dynamic body balance, quality of gait, postural control and quality of life of stroke patients.
The exercises will be conducted and supervised by physiotherapists. During the exercises, patients will be provided with protection against falls and injuries. The methodology of individual exercises will be planned on the basis of scientific publications in which modern technologies were used safely in post-stroke rehabilitation. Therefore, no adverse events except fatigue is expected in patients. Possible side effects will be noted and, if necessary, the studies will be modified and discontinued, with appropriate notification to the Bioethics Committee.
Where is the study run from?
1. Academy of Physical Education in Katowice (Poland)
2. The Medical and Rehabilitation Center ''Solanki'' in Inowroclaw (Poland).
When is the study starting and how long is it expected to run for?
July 2020 to June 2022
Who is funding the study?
The Medical and Rehabilitation Center ''Solanki'' in Inowroclaw (Poland).
European Regional Development Fund for the Kuyavian-Pomeranian Voivodeship, Poland (No. RPKK.01.02.01-04-0016/18).
Who is the main contact?
Laura Piejko
l.piejko@awf.katowice.pl
Contact information
Scientific
The Academy of Physical Education in Katowice
72a Mikolowska Street
Katowice
40-065
Poland
 ORCID ID |
0000-0002-5338-1842 |
|---|---|
| Phone | +48 (0)32 207 53 01 |
| l.piejko@awf.katowice.pl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The effectiveness of the treadmill exercises with controlled balance perturbances in the rehabilitaion of patients with chronic stroke. Randomized clinical trial. |
| Study objectives | 1. The perturbance balance training (PBT) carried out with the use of the treadmill Balance Tutor; MediTouch, Izrael will improve quality of gait of stroke patients. 2.The perturbance balance training (PBT) carried out with the use of the treadmill Balance Tutor; MediTouch, Izrael) will improve static and dynamic body balance of stroke patients. 3. The perturbance balance training (PBT) carried out with the use of the treadmill Balance Tutor; MediTouch, Izrael will improve quality of life of stroke patients. 4.The perturbance balance training (PBT) carried out with the use of the treadmill Balance Tutor; MediTouch, Izrael will improve activities of daily living (ADL). |
| Ethics approval(s) | Approved 09/07/2020, Bioethics Commission for Scientific Research at The Jerzy Kukuczka Academy of Physical Education in Katowice (Mikołowska 72a Street, 40-065 Katowice, Poland; +48 032 2075152; komisjabioetyczna@awf.katowice.pl), ref: 5/2020 |
| Health condition(s) or problem(s) studied | Treadmill perturbance balance training in modern rehabilitation of patients after stroke |
| Intervention | Chronic post-stroke patients, treated in the same Medical and Rehabilitation Center ''Solanki'' in Inowroclaw (Poland) will participate in the study. After the medical examination and meeting the inclusion criteria, 50 patients will be randomly assigned to the experimental (25 patients) and control (25 patients) groups. Treadmill training with controlled body balance perturbations (Balance Tutor; MediTouch, Israel) will be administered to patients in the experimental group (EG). Training with body balance perturbations on the treadmill will be performed 6 days a week (Monday to Saturday) for 30 minutes a day, for 3 weeks.Patients in the control group (CG) will receive traditional ground gait training for 30 minutes a day for 3 weeks, 6 days a week (Monday to Saturday). In addition, all patients in both groups will be subjected to typical post-stroke rehabilitation for 2.5 hours a day, 6 days a week (Monday-Saturday), based on the principles of best clinical practices. The aim of the exercises will be to normalize muscle tone and improve movement patterns. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1.Gait assessed by 10 Metre Walk Test (10MWT), at baseline and after the 3-week rehabilitation period. |
| Key secondary outcome measure(s) |
1. Static and dynamic body balance assessed by Berg Balance Scale (BBS), at baseline and after the 3-week rehabilitation period. |
| Completion date | 30/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Women and men over 18 years of age; 2. First history of ischemic or hemorrhagic brain; 3. The period min. 4 months from the onset of stroke; 4. The patient's consent to participate in the study; 5. Ability to understand and follow the therapist's instructions; 7. Ability to walk independently on a distance of 10 m (allowed to use supporting tools such as a cane, crutch or walker); 8. Walking speed at least 0.4 km/h (enabling walking on a treadmill) |
| Key exclusion criteria | 1. Contraindications to exercises in the study; 2. Subarachnoid hemorrhage; 3. Neurological diseases other than stroke affecting body balance and gait quality; |
| Date of first enrolment | 28/03/2022 |
| Date of final enrolment | 03/06/2022 |
Locations
Countries of recruitment
- Poland
Study participating centres
Katowice
40-065
Poland
Inowroclaw
88-100
Poland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/02/2022: Trial's existence confirmed by Bioethics Commission for Scientific Research at The Jerzy Kukuczka Academy of Physical Education in Katowice.
