Endermotherapy for Children With Developmental Disabilities

Phase 2

Completed

• Conditions: Cerebral Palsy; Developmental Delay
• Interventions: Procedure: Endermotherapy; Procedure: Passive manual stretching

• Registration Number: NCT01207570
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-09-17
• Study First Submitted QC: 2010-09-22
• Study First Posted: 2010-09-23
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2011-08-08
• Results First Submitted QC: 2011-08-08
• Results First Posted: 2011-09-13
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-07
• Last Update Posted: 2011-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Endermotherapy	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.
Passive stretching	Passive manual stretching	The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.

Primary Outcome Measures

Name	Time	Method
Ankle Passive Range of Motion	Day 4 after treatment	Ankle passive range of motion on day 4 after the crossover treatment

Trial Locations

Locations (1)

Heep Hong Society; 🇭🇰 Hong Kong, Hong Kong