Hemiplegia and HemiparesisNCT05983887
The Effect of Therapeutic Climbing on Muscle Strength, Tone and Balance in Hemiplegic Children
A study testing Therapeutic Climbing in people with Hemiplegia and Hemiparesis, run by Pavlos Kitixis at 1 site in Greece.
Trial 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?… Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Hemiplegia and Hemiparesis
- What is being tested?
- Therapeutic Climbing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGreece
- Study dates
- 10 Apr 2023to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 4 to 16 years old
- Children with Hemiplegia
- Evaluated as Level 1 on GMFCS
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hemiplegia and Hemiparesis
- Being tested
- Therapeutic Climbing
- Keywords
- therapeutic climbing, hemiplegia, children, muscle strength, balance
- Medical subject headings
- Hemiplegia, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ClimbingOther
The protocol consists of using an in-door climbing wall as an complementary therapeutic intervention model.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Therapeutic Climbing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Measured using Kinvent K-PUSH Dynamometer and Jamar Hydraulic Hand Dynamometer ; Unit of Measure: Peak Force in Kilograms (higher scores - better outcome)
Measured: 8 weeks (pre-post evaluation)
Balance
Measured using the Timed Up \& Go Test ; Unit of Measure: seconds of completion (higher scores - worse outcome)
Measured: 8 weeks (pre-post evaluation)
Muscle Tone
Evaluated using the Modified Ashworth Scale ; Unit of Measure: Scoring Options (0-4) // (higher scores - worse outcome)
Measured: 8 weeks (pre-post evaluation)
Secondary outcomes (1)
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
Measured: 8 weeks (pre-post evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start10 Apr 2023
- Primary completion31 Aug 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemiplegia and HemiparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pavlos Kitixis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pavlos Kitixis, University of Thessaly
- Investigators
- Thomas Besios, PhD, Study chair, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983887
- Sponsor's protocol ID
- climb_in_hem
- Status last verified
- May 2024
- First submitted
- 30 Jul 2023
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21863133
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Climbing on Muscle Strength, Tone and Balance in Hemiplegic Children: a Preliminary Single-blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05983887
- Acronym / sponsor ID
- climb_in_hem
- Conditions
- Hemiplegia and Hemiparesis
- Keywords
- therapeutic climbing, hemiplegia, children, muscle strength, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Pavlos KitixisUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The participants in this group continue their conventional intervention protocol without using the climbing instructions. |
| Climbing Group | Experimental | Other: Therapeutic ClimbingThe participants in this group continue their conventional intervention protocol plus an in-door climbing intervention protocol. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children from 4 to 16 years old
- Children with Hemiplegia
- Evaluated as Level 1 on GMFCS
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic ClimbingThe protocol consists of using an in-door climbing wall as an complementary therapeutic intervention model. | Other | Climbing Group |
Primary outcome
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)
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)
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)
1 secondary outcome
Normative Strength Data Comparison
Time frame: 8 weeks (pre-post evaluation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Background: PubMed 21863133Buechter 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.
- The effect of therapeutic climbing on gross motor function in hemiplegic cerebral palsy. A pilot single-case experimental design study (SCED)Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hemiplegia and Hemiparesis
Not yet recruiting
Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
Hemiplegia, Hemiparesis
Recruiting
High-Intensity Laser Therapy in Hemiplegic Shoulder Pain
Hemiplegia and/or Hemiparesis Following Stroke
Active, not recruiting
rTMS Plus CCFES-mediated Functional Task Practice for Severe Stroke
Stroke, Hemiplegia
Active, not recruiting
Robot-Assisted Mirror Therapy in the Rehabilitation of Hemiparetic Cerebral Palsy
Cerebral Palsy (CP), Hemiparetic Cerebral Palsy
Active, not recruiting
The Effect of Good Limb Position Management Assistive Devices on Preventing Shoulder Subluxation in Hemiplegic Patients
Hemiplegia and/or Hemiparesis Following Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Besios, PhD study chair
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Climbing in people with Hemiplegia and Hemiparesis, run by Pavlos Kitixis at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength (time frame: 8 weeks (pre-post evaluation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05983887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.