Text Size

Endermotherapy for Children With Developmental Disabilities

This study has been completed.
Sponsor:
Collaborator:
Phoelia Co. Ltd.
Information provided by (Responsible Party):
Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01207570
First received: September 17, 2010
Last updated: October 7, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Cerebral Palsy
Developmental Delay
 Procedure: Endermotherapy
Procedure: Passive manual stretching
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Endermotherapy on Passive Ankle Range of Motion in Children With Developmental Disabilities

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Ankle Passive Range of Motion [ Time Frame: day 1 before treatment ] [ Designated as safety issue: No ]
    The ankle passive range of motion will be measured by a Myrin goniometer.

  • Ankle Passive Range of Motion [ Time Frame: day 4 before treatment ] [ Designated as safety issue: No ]
    Ankle passive range of motion at day 4 before the crossover treatment

  • Ankle Passive Range of Motion [ Time Frame: Day 1 after treatment ] [ Designated as safety issue: No ]
    Ankle dorsiflexion passive range of motion

  • Ankle Passive Range of Motion [ Time Frame: Day 4 after treatment ] [ Designated as safety issue: No ]
    Ankle passive range of motion on day 4 after the crossover treatment


Enrollment: 54
Study Start Date: February 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Procedure: 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.
Active Comparator: Passive stretching
The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
 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.

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207570

Locations
Hong Kong
Heep Hong Society
Hong Kong, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
Phoelia Co. Ltd.
Investigators
Principal Investigator: Marco Y P, PhD The Hong Kong Polytechnic University
  More Information

No publications provided

Responsible Party: Marco Yiu-Chung Pang, Associate Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01207570     History of Changes
Other Study ID Numbers: HSEARS20091207001
Study First Received: September 17, 2010
Results First Received: August 8, 2011
Last Updated: October 7, 2011
Health Authority: Hong Kong: Research Office,The Hong Kong Polytechnic University

Keywords provided by The Hong Kong Polytechnic University:
flexibility
muscle
stretching
cerebral palsy
developmental

Additional relevant MeSH terms:
Cerebral Palsy
Developmental Disabilities
Brain Damage, Chronic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013