search
Back to results

Endermotherapy for Children With Developmental Disabilities

Primary Purpose

Cerebral Palsy, Developmental Delay

Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Endermotherapy
Passive manual stretching
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring flexibility, muscle, stretching, cerebral palsy, developmental

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Other serious illnesses that preclude participation

Sites / Locations

  • Heep Hong Society

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endermotherapy

Passive stretching

Arm Description

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.

The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.

Outcomes

Primary Outcome Measures

Ankle Passive Range of Motion
The ankle passive range of motion will be measured by a Myrin goniometer.
Ankle Passive Range of Motion
Ankle passive range of motion at day 4 before the crossover treatment
Ankle Passive Range of Motion
Ankle dorsiflexion passive range of motion
Ankle Passive Range of Motion
Ankle passive range of motion on day 4 after the crossover treatment

Secondary Outcome Measures

Full Information

First Posted
September 17, 2010
Last Updated
October 7, 2011
Sponsor
The Hong Kong Polytechnic University
Collaborators
Phoelia Co. Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01207570
Brief Title
Endermotherapy for Children With Developmental Disabilities
Official Title
Effect of Endermotherapy on Passive Ankle Range of Motion in Children With Developmental Disabilities
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Phoelia Co. Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Developmental Delay
Keywords
flexibility, muscle, stretching, cerebral palsy, developmental

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endermotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Passive stretching
Arm Type
Active Comparator
Arm Description
The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
Intervention Type
Procedure
Intervention Name(s)
Endermotherapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Passive manual stretching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ankle Passive Range of Motion
Description
The ankle passive range of motion will be measured by a Myrin goniometer.
Time Frame
day 1 before treatment
Title
Ankle Passive Range of Motion
Description
Ankle passive range of motion at day 4 before the crossover treatment
Time Frame
day 4 before treatment
Title
Ankle Passive Range of Motion
Description
Ankle dorsiflexion passive range of motion
Time Frame
Day 1 after treatment
Title
Ankle Passive Range of Motion
Description
Ankle passive range of motion on day 4 after the crossover treatment
Time Frame
Day 4 after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Other serious illnesses that preclude participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Y P, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heep Hong Society
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Learn more about this trial

Endermotherapy for Children With Developmental Disabilities

We'll reach out to this number within 24 hrs