Clinical trial NCT04328168: Comparision Of The Effectiveness Of Physiotherapy Methods
Official title: Comparision Of The Effectiveness Of Conventional Physiotherapy After Botulinum Toxin Injection In Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Botulinum-toxin, cerebral-palsy, robot-assisted therapy
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-03-31
Enrollment: 28
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 28 patients who were followed-up in our clinic and received botulinum toxin injection of lower extremities in the last month were randomized to two groups in the study. Group 1 received conventional physiotherapy and Group 2 received robot-assisted gait training.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A total of 28 patients who were followed-up in our clinic and received botulinum toxin injection of lower extremities in the last month were randomized to two groups in the study. Group 1 received conventional physiotherapy and Group 2 received robot-assisted gait training. The treatment period was 30 min/day, five sessions in a week, 15 sessions in total, for both groups. The study population was evaluated using range of joint motion evaluation chart, the Modified Ashworth Scale, The Gross Motor Function Classification System, The Berg Balance Scale, the functional independence measure for children, and the Edinburgh Visual Gait Score

Detailed description: A total of 28 patients who were followed-up in our clinic and received botulinum toxin injection of lower extremities in the last month were randomized to two groups in the study. Group 1 received conventional physiotherapy and Group 2 received robot-assisted gait training. The treatment period was 30 min/day, five sessions in a week, 15 sessions in total, for both groups. The study population was evaluated using range of joint motion evaluation chart, the Modified Ashworth Scale, The Gross Motor Function Classification System, The Berg Balance Scale, the functional independence measure for children, and the Edinburgh Visual Gait Score.

Eligibility criteria: Inclusion Criteria:

* Aged 4\>, \<16 with CP diagnosis
* Walking diffculties due to the spasticity of lower extremities,
* Level I-IV on the Gross Motor Function Classification System.

Exclusion Criteria:

* MAS Level IV spasticity, contractures, or rigidity in the lower extremities,
* A limb length inequality of \>2 cm,
* Hypotonic CP,
* Having drug-related refractory epilepsy,
* Undergoing intrathecal baclofen pump surgery,
* Surgical interventions in the lower extremities in the last year,
* Scoliosis angle of \>30°,
* Complicated osteoporosis (nontraumatic fracture...),
* Cardiovascular instability,
* GMFCS Level V,
* Metabolic disorder, genetic disease, neurodegenerative and neuromuscular diseases.

Primary outcomes:
measure: The Gross Motor Function Classification System (GMFCS)
timeFrame: 3 weeks
measure: The Edinburgh Visual Gait Scale (EVGS)
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: