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Evaluation of the effectiveness of physical therapy for people with infantile cerebral palsy using the KRISAF robot assistant

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10054755
Enrollment
120
Registered
2025-02-26
Start date
2025-01-06
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral palsy Nervous System Diseases

Interventions

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). Rand

Sponsors

Aspect Medical
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Neurological examination on the 1st day and the 10th day of classes

Countries

Belarus, Russian Federation

Contacts

Public ContactVera;Tatiana Zmanovskaya;Poltavskaya

;

tysayny@yandex.ru;tysayny@yandex.ru+7 (0)89193740305;+7 (0)89193740305

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026