NCT05983887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

December 29, 2025

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

July 30, 2023

Last Update Submit

December 19, 2025

Conditions

Keywords

therapeutic climbinghemiplegiachildrenmuscle strengthbalance

Outcome Measures

Primary Outcomes (3)

  • Muscle Strength

    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

    Measured using the Timed Up \& Go Test ; Unit of Measure: seconds of completion (higher scores - worse outcome)

    8 weeks (pre-post evaluation)

  • Muscle Tone

    Evaluated using the Modified Ashworth Scale ; Unit of Measure: Scoring Options (0-4) // (higher scores - worse outcome)

    8 weeks (pre-post evaluation)

Secondary Outcomes (1)

  • Normative Strength Data Comparison

    8 weeks (pre-post evaluation)

Study Arms (2)

Control Group

NO INTERVENTION

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

Climbing Group

EXPERIMENTAL

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

Other: Therapeutic Climbing

Interventions

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

Climbing Group

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children from 4 to 16 years old
  • Children with Hemiplegia
  • Evaluated as Level 1 on GMFCS

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physiotherapy

Lamia, Phthiotis, 35100, Greece

Location

Related Publications (1)

  • 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.

    PMID: 21863133BACKGROUND

Related Links

MeSH Terms

Conditions

HemiplegiaParesis

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Besios, PhD

    University of Thessaly

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-blind Randomised Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 30, 2023

First Posted

August 9, 2023

Study Start

April 10, 2023

Primary Completion

August 31, 2023

Study Completion

September 20, 2023

Last Updated

December 29, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations