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Endermotherapy for Children With Developmental Disabilities

NCT ID: NCT01207570

Last Updated: 2011-10-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy Developmental Delay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Endermotherapy

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.

Group Type EXPERIMENTAL

Endermotherapy

Intervention Type PROCEDURE

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 stretching

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

Group Type ACTIVE_COMPARATOR

Passive manual stretching

Intervention Type PROCEDURE

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.

Interventions

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Endermotherapy

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

Passive manual stretching

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phoelia Co. Ltd.

UNKNOWN

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Marco Yiu-Chung Pang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marco Y P, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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Heep Hong Society

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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HSEARS20091207001

Identifier Type: -

Identifier Source: org_study_id