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Comparision Of The Effectiveness Of Physiotherapy Methods

NCT ID: NCT04328168

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-15

Study Completion Date

2017-01-15

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
Participant

Study Groups

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Group1

Conventional Physiotherapy

Group Type ACTIVE_COMPARATOR

ROM exercises, stretching, positioning, gait training

Intervention Type PROCEDURE

Group2

robot-assisted gait training

Group Type ACTIVE_COMPARATOR

by two physiotherapist under the supervision of a doctor

Intervention Type PROCEDURE

Interventions

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ROM exercises, stretching, positioning, gait training

Intervention Type PROCEDURE

by two physiotherapist under the supervision of a doctor

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kayseri Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Ayşe Güç

Kayseri Education and Research State Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2016/442

Identifier Type: -

Identifier Source: org_study_id