- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05983887
The Effect of Therapeutic Climbing on Muscle Strength, Tone and Balance in Hemiplegic Children
The Effect of Therapeutic Climbing on Muscle Strength, Tone and Balance in Hemiplegic Children: a Preliminary Single-blind Randomised Controlled Trial
The goal of this randomised controlled trial is to learn about the effect of therapeutic climbing in hemiplegic children. The main questions it aims to answer are:
Does climbing affect muscle strength and tone? What is its connection between normative data drawn from healthy children? How can it affect balance?
Participants (children) will be asked to complete an series of movements used in sports climbing, such as inside-flag, back-flag and horizontal traverse, while hanging on an in-door climbing wall.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Phthiotis
-
Lamia, Phthiotis, Greece, 35100
- Department of Physiotherapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children from 4 to 16 years old
- Children with Hemiplegia
- Evaluated as Level 1 on GMFCS
Exclusion Criteria:
- Botulinum toxin injection in last 6 months
- Surgery in the last 1 year (myofascial lengthening etc.)
- Children with poor cognitive skills (not following instructions etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
The participants in this group continue their conventional intervention protocol without using the climbing instructions.
|
|
|
Experimental: Climbing Group
The participants in this group continue their conventional intervention protocol plus an in-door climbing intervention protocol.
|
The protocol consists of using an in-door climbing wall as an complementary therapeutic intervention model.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Strength
Time Frame: 8 weeks (pre-post evaluation)
|
Measured using Kinvent K-PUSH Dynamometer and Jamar Hydraulic Hand Dynamometer ; Unit of Measure: Peak Force in Kilograms (higher scores - better outcome)
|
8 weeks (pre-post evaluation)
|
|
Balance
Time Frame: 8 weeks (pre-post evaluation)
|
Measured using the Timed Up & Go Test ; Unit of Measure: seconds of completion (higher scores - worse outcome)
|
8 weeks (pre-post evaluation)
|
|
Muscle Tone
Time Frame: 8 weeks (pre-post evaluation)
|
Evaluated using the Modified Ashworth Scale ; Unit of Measure: Scoring Options (0-4) // (higher scores - worse outcome)
|
8 weeks (pre-post evaluation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Normative Strength Data Comparison
Time Frame: 8 weeks (pre-post evaluation)
|
Comparison of normative values of the Jamar Hydraulic Hand Dynamometer of Healthy and Hemiplegic Children ; Unit of Measure: Difference of Peak Force in Kilograms
|
8 weeks (pre-post evaluation)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Thomas Besios, PhD, University of Thessaly
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- climb_in_hem
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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