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The Effect of Therapeutic Climbing on Muscle Strength, Tone and Balance in Hemiplegic Children

Primary Purpose

Hemiplegia and Hemiparesis

Status
Active
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Therapeutic Climbing
Sponsored by
Pavlos Kitixis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia and Hemiparesis focused on measuring therapeutic climbing, hemiplegia, children, muscle strength, balance

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Department of Physiotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Climbing Group

Arm Description

The participants in this group continue their conventional intervention protocol without using the climbing instructions.

The participants in this group continue their conventional intervention protocol plus an in-door climbing intervention protocol.

Outcomes

Primary Outcome Measures

Muscle Strength
Measured using Kinvent K-PUSH Dynamometer and Jamar Hydraulic Hand Dynamometer ; Unit of Measure: Peak Force in Kilograms
Balance
Measured using the Timed Up & Go Test ; Unit of Measure: seconds of completion
Muscle Tone
Evaluated using the Modified Ashworth Scale ; Unit of Measure: Scoring Options (0-4)

Secondary Outcome Measures

Normative Strength Data Comparison
Comparison of normative values of the Jamar Hydraulic Hand Dynamometer of Healthy and Hemiplegic Children ; Unit of Measure: Difference of Peak Force in Kilograms

Full Information

First Posted
July 30, 2023
Last Updated
August 6, 2023
Sponsor
Pavlos Kitixis
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1. Study Identification

Unique Protocol Identification Number
NCT05983887
Brief Title
The Effect of Therapeutic Climbing on Muscle Strength, Tone and Balance in Hemiplegic Children
Official Title
The Effect of Therapeutic Climbing on Muscle Strength, Tone and Balance in Hemiplegic Children: a Preliminary Single-blind Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pavlos Kitixis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia and Hemiparesis
Keywords
therapeutic climbing, hemiplegia, children, muscle strength, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind Randomised Controlled Trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The participants in this group continue their conventional intervention protocol without using the climbing instructions.
Arm Title
Climbing Group
Arm Type
Experimental
Arm Description
The participants in this group continue their conventional intervention protocol plus an in-door climbing intervention protocol.
Intervention Type
Other
Intervention Name(s)
Therapeutic Climbing
Intervention Description
The protocol consists of using an in-door climbing wall as an complementary therapeutic intervention model.
Primary Outcome Measure Information:
Title
Muscle Strength
Description
Measured using Kinvent K-PUSH Dynamometer and Jamar Hydraulic Hand Dynamometer ; Unit of Measure: Peak Force in Kilograms
Time Frame
8 weeks (pre-post evaluation)
Title
Balance
Description
Measured using the Timed Up & Go Test ; Unit of Measure: seconds of completion
Time Frame
8 weeks (pre-post evaluation)
Title
Muscle Tone
Description
Evaluated using the Modified Ashworth Scale ; Unit of Measure: Scoring Options (0-4)
Time Frame
8 weeks (pre-post evaluation)
Secondary Outcome Measure Information:
Title
Normative Strength Data Comparison
Description
Comparison of normative values of the Jamar Hydraulic Hand Dynamometer of Healthy and Hemiplegic Children ; Unit of Measure: Difference of Peak Force in Kilograms
Time Frame
8 weeks (pre-post evaluation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Besios, PhD
Organizational Affiliation
University of Thessaly
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Physiotherapy
City
Lamía
State/Province
Phthiotis
ZIP/Postal Code
35100
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21863133
Citation
Buechter RB, Fechtelpeter D. Climbing for preventing and treating health problems: a systematic review of randomized controlled trials. Ger Med Sci. 2011;9:Doc19. doi: 10.3205/000142. Epub 2011 Aug 9.
Results Reference
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The Effect of Therapeutic Climbing on Muscle Strength, Tone and Balance in Hemiplegic Children

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