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Comparision Of The Effectiveness Of Physiotherapy Methods

Comparision Of The Effectiveness Of Conventional Physiotherapy After Botulinum Toxin Injection In Children With Cerebral Palsy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04328168
Enrollment
28
Registered
2020-03-31
Start date
2016-08-15
Completion date
2017-01-15
Last updated
2020-03-31

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

Conditions

Cerebral Palsy

Keywords

Botulinum-toxin, cerebral-palsy, robot-assisted therapy

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.

Interventions

PROCEDUREROM exercises, stretching, positioning, gait training
PROCEDUREby two physiotherapist under the supervision of a doctor

Sponsors

Kayseri Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Masking description

Participant

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.

Eligibility

Sex/Gender
ALL
Age
7 Years to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The Gross Motor Function Classification System (GMFCS)3 weeksThe Gross Motor Function Classification System or GMFCS is a 5 level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities.
The Edinburgh Visual Gait Scale (EVGS)3 weeksThe Edinburgh visual gait score is an evaluative tool that uses software and video cameras to provide 3D video gait analysis as well as onscreen drawing and measurement tools to evaluate each portion of gait. The software will then generate a EVGS report, with illustrative images from the video if desired, in PDF format.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026