Endermotherapy for Children With Developmental Disabilities

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Developmental Delay
• Intervention / Treatment: Procedure: Endermotherapy; Procedure: Passive manual stretching

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Heep Hong Society

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle Passive Range of Motion	The ankle passive range of motion will be measured by a Myrin goniometer.	day 1 before treatment
Ankle Passive Range of Motion	Ankle passive range of motion at day 4 before the crossover treatment	day 4 before treatment
Ankle Passive Range of Motion	Ankle dorsiflexion passive range of motion	Day 1 after treatment
Ankle Passive Range of Motion	Ankle passive range of motion on day 4 after the crossover treatment	Day 4 after treatment

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Phoelia Co. Ltd.
• Investigators: Principal Investigator: Marco Y P, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: September 17, 2010
• First Submitted That Met QC Criteria: September 22, 2010
• First Posted (ESTIMATE): September 23, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 10, 2011
• Last Update Submitted That Met QC Criteria: October 7, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: muscle; cerebral palsy; developmental; stretching; flexibility
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Neurodevelopmental Disorders; Cerebral Palsy; Developmental Disabilities
• Other Study ID Numbers: HSEARS20091207001