Evaluation of the effectiveness of physical therapy for people with infantile cerebral palsy using the KRISAF robot assistant
| ISRCTN | ISRCTN10054755 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10054755 |
- Submission date
- 10/02/2025
- Registration date
- 26/02/2025
- Last edited
- 06/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
This is an evaluation of the effectiveness of physical therapy for people with cerebral palsy using the KRISAF assistant robot. Infantile cerebral palsy (CP) is a condition in which a child's muscles and movements are disrupted. This makes it difficult for children to walk, run, stand, and perform other movements. They use physical therapy to improve their condition but this requires special devices. One of these devices is the KRISAF robot assistant. KRISAF helps children perform exercises that they would not be able to do on their own. It supports their body as they move and makes sure they do everything right. To assess the effectiveness of this method, a special scale is used. This helps measure how much the child's motor skills have improved after using a device KRISAF. The higher the score on the scale, the better the child copes with the child's movements. The results show that KRISAF classes can help children with cerebral palsy improve their motor skills. A pilot study was conducted in the medical center of the city of Yekaterinburg, which showed the effectiveness of using the robotic complex. It was decided to repeat this study in several health centers. The aim of the study is to prove the effectiveness of rehabilitation using a robotic complex, which can make children's lives more comfortable, active and independent.
Who can participate?
Children 6-12 years of age with cerebral palsy
What does the study involve?
Participants are randomly allocated to one of two groups, one of which will receive standard treatment and the other standard treatment
including classes at the Krisaf complex.
What are the possible benefits and risks of participating?
The main advantage of the study is the new technology implemented in the Krisaf robotics complex. This complex helps in maintaining and restoring the range of motion in the joints, normalizing muscle tone and restoring proper execution of body movements. The technology has minimal risks, such as discomfort during sports. If you feel uncomfortable, you can interrupt the session.
Where is the study run from?
Aspect Medical (Russia)
When is the study starting and how long is it expected to run for?
October 2024 to October 2025
Who is funding the study?
Aspect Medical (Russia)
Who is the main contact?
Tatyana S. Poltavskaya, tysayny@yandex.ru
Contact information
Public, Scientific, Principal Investigator
Tumen state
Tumen
625000
Russian Federation
| Phone | +7 (0)89193740305 |
|---|---|
| tysayny@yandex.ru |
Public, Scientific
Ekaterinburg
Ekaterinburg
620146
Russian Federation
 ORCID ID |
0000-0003-0139-3726 |
|---|---|
| Phone | +7 (0)89193740305 |
| tysayny@yandex.ru |
Study information
| Study design | Randomized controlled interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Evaluation of the effectiveness of locomotor therapy in a supportless state using the robot assistive complex KRISAF in patients with cerebral palsy based on the GMFM 66 scale |
| Study acronym | KRISAF |
| Study objectives | Randomized controlled multicenter study of the effectiveness and safety of a new method of rehabilitation therapy for motor disorders in patients with cerebral palsy with spastic diplegia using a robotic complex for locomotor therapy in an unsupported state |
| Ethics approval(s) |
Approved 23/12/2024, Committee on Ethics and Deontology of the healthcare institution "Minsk city center for medical rehabilitation of children with Neuropsychiatric diseases" (St Uralskaya 5, Minsk, 220004, Belarus; +375 (17)239-59-12; firststep@cu.bc.by), ref: 2 |
| Health condition(s) or problem(s) studied | Cerebral palsy |
| Intervention | Participants diagnosed with CP with spastic diplegia classified as Gross Motor Function Classification Scale (GMFCS) Levels I-V will be recruited and divided equally into two groups (G1 and G2). Randomization will be performed using the envelope method. The first group (G1) will receive rehabilitation at the complex for locomotor therapy "Krisaf", 8-10 sessions including swimming, jumping, crawling, walking for 5-7 minutes, and jumping-assisted mode for 3-5 minutes. There are only 10 sessions, an average of 30 minutes each. Standard methods of rehabilitation. Control group (G2): Standard rehabilitation methods. Standard complex of rehabilitation including kinesiotherapy and mechanotherapy. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Robot assistive complex Krisaf |
| Primary outcome measure | Functional state and motor function measured using the Tardieu scale and Gross Motor Function Measure 66 (GMFM-66) on the 1st day and the 10th day of classes |
| Secondary outcome measures | Neurological examination on the 1st day and the 10th day of classes |
| Overall study start date | 22/10/2024 |
| Completion date | 22/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Patients with a verified diagnosis of cerebral palsy (spastic forms of cerebral palsy, diplegia and quadriplegia) 2. Aged 6-12 years 3. GMFCS level 1-4 4. The presence of communicative contact with the child (Communication Function Classification System [CFCS] 1-3) 5. Voluntary consent to conduct the study |
| Key exclusion criteria | 1. Acute inflammatory diseases 2. Somatic pathology in the stage of decompensation 3. Severe orthopedic disorders (hip dislocation) 4. Lack of communication contact with the child 5. Epilepsy 6. Lack of voluntary consent |
| Date of first enrolment | 06/01/2025 |
| Date of final enrolment | 06/04/2025 |
Locations
Countries of recruitment
- Belarus
- Russian Federation
Study participating centres
Minsk
220004
Belarus
Ekaterinburg
620000
Russian Federation
223054
Russian Federation
Sponsor information
Industry
Ekaterinburg st Uralskaya 86\1
Ekaterinburg
620041
Russian Federation
| Phone | +7 (0)8 (343) 363-03-12 |
|---|---|
| mail@aspectmedical.eu |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Location
- Ireland
Results and Publications
| Intention to publish date | 05/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Publishing results in a peer-reviewed journal |
| IPD sharing plan | The dataset generated and analysed during the current will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | CRF in Russan | 06/06/2025 | No | No |
Additional files
- ISRCTN10054755 CRF in Russian клинический протокол.pdf
- CRF in Russan
Editorial Notes
06/06/2025: A CRF was uploaded as an additional file.
10/02/2025: Study's existence confirmed by the Committee on Ethics and Deontology of the healthcare institution "Minsk city center for medical rehabilitation of children with neuropsychiatric diseases".
