Cerebral PalsyPhase 2NCT01207570
Endermotherapy for Children With Developmental Disabilities
A Phase 2 study testing Endermotherapy and Passive manual stretching in people with Cerebral Palsy and Developmental Delay, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Children with developmental disabilities often sustain decreased range of motion in their extremities. The decrease in flexibility may be due to neuromuscular disorders such as spasticity or dystonia. Other causes may be imbalance in muscle strength surrounding a joint, leading to inappropriate habitual posture. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Cerebral Palsy, Developmental Delay
- What is being tested?
- Endermotherapy and Passive manual stretching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteHong Kong
- Study dates
- Feb 2010to May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged between 2 and 6.
- children with diagnosis of cerebral palsy or developmental disabilities.
- Has limited ankle dorsiflexion range of motion (less than 20 degrees)
Who cannot join
- Other serious illnesses that preclude participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Endermotherapy on Passive Ankle Range of Motion in Children With Developmental Disabilities
Children with developmental disabilities often sustain decreased range of motion in their extremities. The decrease in flexibility may be due to neuromuscular disorders such as spasticity or dystonia. Other causes may be imbalance in muscle strength surrounding a joint, leading to inappropriate habitual posture. Over time, muscle contracture may result for those muscle groups that are placed in a shortened position for an extended period of time. The most common site of muscle contractures among these children are gastrocnemius/soleus (lower limbs), and latissimus dorsi muscles (upper limbs). Muscle contractures can lead to further decline in functional abilities. Therefore, it is important to identify effective intervention strategies to enhance or maintain muscle flexibility in children with developmental dysfunctions.
Commercially available endermotherapy device has been used to soften scar tissue following burn injuries. The mechanical stimulation applied may also have beneficial effects on relaxing the muscle tissue. The overall aim of the proposed study is to determine whether endermotherapy treatment has immediate effect in improving joint range of motion among children with developmental disabilities.
The research hypothesis is that children in the endermotherapy group will have significantly more gain in ankle passive range of motion than those in the control group.
- Conditions
- Cerebral Palsy, Developmental Delay
- Being tested
- Endermotherapy, Passive manual stretching
- Keywords
- flexibility, muscle, stretching, cerebral palsy, developmental
- Medical subject headings
- Cerebral Palsy, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndermotherapyProcedure or surgery
The subjects will receive a single session of endermotherapy applied to the gastrocnemius/soleus muscle on the more affected side for 5 minutes. The treatment will be conducted by a qualified physiotherapist.
Passive manual stretchingProcedure or surgery
The subjects will receive a single session of passive manual stretching of the gastrocnemius/soleus muscle on the more affected side. The treatment will be given by a qualified physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Endermotherapy | Experimental | The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist. Receives: Procedure: Endermotherapy |
| Passive stretching | Active comparator | The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes. Receives: Procedure: Passive manual stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Passive Range of Motion
The ankle passive range of motion will be measured by a Myrin goniometer.
Measured: day 1 before treatment
Ankle Passive Range of Motion
Ankle passive range of motion at day 4 before the crossover treatment
Measured: day 4 before treatment
Ankle Passive Range of Motion
Ankle dorsiflexion passive range of motion
Measured: Day 1 after treatment
Ankle Passive Range of Motion
Ankle passive range of motion on day 4 after the crossover treatment
Measured: Day 4 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral PalsyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Phoelia Co. Ltd.
- Responsible party
- Principal investigator, Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
- Investigators
- Marco Y P, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207570
- Sponsor's protocol ID
- HSEARS20091207001
- Status last verified
- Oct 2011
- First submitted
- 17 Sep 2010
- Last updated
- 10 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endermotherapy on Passive Ankle Range of Motion in Children With Developmental Disabilities
- ClinicalTrials.gov ID
- NCT01207570
- Acronym / sponsor ID
- HSEARS20091207001
- Conditions
- Cerebral Palsy, Developmental Delay
- Keywords
- flexibility, muscle, stretching, cerebral palsy, developmental
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Phoelia Co. Ltd.
- Study start
- Feb 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Posted 13 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children with developmental disabilities often sustain decreased range of motion in their extremities. The decrease in flexibility may be due to neuromuscular disorders such as spasticity or dystonia. Other causes may be imbalance in muscle strength surrounding a joint, leading to inappropriate habitual posture. Over time, muscle contracture may result for those muscle groups that are placed in a shortened position for an extended period of time. The most common site of muscle contractures among these children are gastrocnemius/soleus (lower limbs), and latissimus dorsi muscles (upper limbs). Muscle contractures can lead to further decline in functional abilities. Therefore, it is important to identify effective intervention strategies to enhance or maintain muscle flexibility in children with developmental dysfunctions.
Commercially available endermotherapy device has been used to soften scar tissue following burn injuries. The mechanical stimulation applied may also have beneficial effects on relaxing the muscle tissue. The overall aim of the proposed study is to determine whether endermotherapy treatment has immediate effect in improving joint range of motion among children with developmental disabilities.
The research hypothesis is that children in the endermotherapy group will have significantly more gain in ankle passive range of motion than those in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endermotherapy | Experimental | Procedure: EndermotherapyThe subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist. |
| Passive stretching | Active comparator | Procedure: Passive manual stretchingThe subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children aged between 2 and 6.
- children with diagnosis of cerebral palsy or developmental disabilities.
- Has limited ankle dorsiflexion range of motion (less than 20 degrees)
Key exclusion criteria (1 listed)
- Other serious illnesses that preclude participation
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 |
|---|---|---|
| EndermotherapyThe subjects will receive a single session of endermotherapy applied to the gastrocnemius/soleus muscle on the more affected side for 5 minutes. The treatment will be conducted by a qualified physiotherapist. | Procedure or surgery | Endermotherapy |
| Passive manual stretchingThe subjects will receive a single session of passive manual stretching of the gastrocnemius/soleus muscle on the more affected side. The treatment will be given by a qualified physiotherapist. | Procedure or surgery | Passive stretching |
Primary outcome
Ankle Passive Range of Motion
Time frame: day 1 before treatment
The ankle passive range of motion will be measured by a Myrin goniometer.
Ankle Passive Range of Motion
Time frame: day 4 before treatment
Ankle passive range of motion at day 4 before the crossover treatment
Ankle Passive Range of Motion
Time frame: Day 1 after treatment
Ankle dorsiflexion passive range of motion
Ankle Passive Range of Motion
Time frame: Day 4 after treatment
Ankle passive range of motion on day 4 after the crossover treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marco Y P, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endermotherapy and Passive manual stretching in people with Cerebral Palsy and Developmental Delay, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 1 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 10 Oct 2011. 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 Hong Kong. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ankle Passive Range of Motion (time frame: day 1 before treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2011.