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

Sponsor
Pavlos Kitixis (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05983887
Collaborator
(none)
12
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2
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Therapeutic Climbing
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single-blind Randomised Controlled TrialSingle-blind Randomised Controlled Trial
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Therapeutic Climbing on Muscle Strength, Tone and Balance in Hemiplegic Children: a Preliminary Single-blind Randomised Controlled Trial
Actual Study Start Date :
Apr 10, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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.

Other: Therapeutic Climbing
The protocol consists of using an in-door climbing wall as an complementary therapeutic intervention model.

Outcome Measures

Primary Outcome Measures

  1. Muscle Strength [8 weeks (pre-post evaluation)]

    Measured using Kinvent K-PUSH Dynamometer and Jamar Hydraulic Hand Dynamometer ; Unit of Measure: Peak Force in Kilograms

  2. Balance [8 weeks (pre-post evaluation)]

    Measured using the Timed Up & Go Test ; Unit of Measure: seconds of completion

  3. Muscle Tone [8 weeks (pre-post evaluation)]

    Evaluated using the Modified Ashworth Scale ; Unit of Measure: Scoring Options (0-4)

Secondary Outcome Measures

  1. Normative Strength Data Comparison [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Physiotherapy Lamía Phthiotis Greece 35100

Sponsors and Collaborators

  • Pavlos Kitixis

Investigators

  • Study Chair: Thomas Besios, PhD, University of Thessaly

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Pavlos Kitixis, Principal Investigator, University of Thessaly
ClinicalTrials.gov Identifier:
NCT05983887
Other Study ID Numbers:
  • 489/10-4-2023
First Posted:
Aug 9, 2023
Last Update Posted:
Aug 9, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pavlos Kitixis, Principal Investigator, University of Thessaly
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2023