Physiotherapy After Botulinum Toxin Injection and Serial Casting

NCT ID: NCT05312125

Last Updated: 2023-06-15

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

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-06

Study Completion Date

2023-04-20

Brief Summary

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The effects of different physiotherapy programs on children with cerebral palsy who have been received botulinum toxin injection and serial casting application will be determined.

Detailed Description

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CP children who underwent botulinum toxin injection to medial gastrocnemius muscle and serial casting application in last two months will be included in the study. The effects of traditional physiotherapy and downhill backward treadmill training plus to traditional physiotherapy on muscle morphology, activity, walking, quality of life and selectivity will be determined.

Conditions

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Cerebral Palsy Cerebral Palsy, Spastic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups of children with Cerebral palsy are going to be involved at the same time. One of the groups will be enrolled in the routine physiotherapy intervention. The other group will be enrolled to the routine physiotherapy intervention + backward downhill walking.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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control group

Children in this group will take routine physiotherapy (stretching, strengthening) program during 6 weeks. 3 days/week.

Group Type ACTIVE_COMPARATOR

routine physiotherapy

Intervention Type PROCEDURE

Children in one of the groups will take routine physiotherapy programme

intervention group

Children in this group will take routine physiotherapy (stretching, strengthening) program + backward downhill walking (10 minutes in a day) during 6 weeks. 3 days/week.

Group Type ACTIVE_COMPARATOR

backward downhill walking

Intervention Type PROCEDURE

Children in the intervention group will take backward downhill walking program plus to routine physiotherapy.

routine physiotherapy

Intervention Type PROCEDURE

Children in one of the groups will take routine physiotherapy programme

Interventions

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backward downhill walking

Children in the intervention group will take backward downhill walking program plus to routine physiotherapy.

Intervention Type PROCEDURE

routine physiotherapy

Children in one of the groups will take routine physiotherapy programme

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Being diagnosed with cerebral palsy (CP) (hemiplegic-diplegic)
2. To have undergone botulinum toxin and serial casting interventions in the last 2 months
3. to be between 5-10 years old
4. Being at the level of I-II-III (ambulatory or assisted ambulatory) according to Gross Motor Function Classification System
5. To have the mental competence to understand and apply assessments and exercises

Exclusion Criteria

1. Having undergone surgery involving the lower extremity in the last 6 months
2. Refusing to participate in the study
3. Having other accompanying neurometabolic or orthopedic disorders
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gulhane Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Ankara Eğitim ve Araştırma Hastanesi

UNKNOWN

Sponsor Role collaborator

Gazi University

OTHER

Sponsor Role lead

Responsible Party

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pelin atalan

Physiotherapist, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pelin Atalan

Izmir, Bornova, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GaziUniPA

Identifier Type: -

Identifier Source: org_study_id

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