Comparision Of The Effectiveness Of Physiotherapy Methods

NCT04328168 | Completed

• 1 other identifier: 2016/442
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cerebral Palsy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• The Gross Motor Function Classification System (GMFCS)

  The 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.

  3 weeks

• The Edinburgh Visual Gait Scale (EVGS)

  The 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.

  3 weeks

Study Arms (2)

Group1

ACTIVE COMPARATOR

Conventional Physiotherapy

Procedure: ROM exercises, stretching, positioning, gait training

Group2

ACTIVE COMPARATOR

robot-assisted gait training

Procedure: by two physiotherapist under the supervision of a doctor

Interventions

ROM exercises, stretching, positioning, gait training PROCEDURE

Group1

by two physiotherapist under the supervision of a doctor PROCEDURE

Group2

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kayseri Education and Research Hospital: lead

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kayseri Education and Research State Hospital

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2020
• First Posted: March 31, 2020
• Study Start: August 15, 2016
• Primary Completion: October 15, 2016
• Study Completion: January 15, 2017
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share