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Clinical Trials/NCT01207570
NCT01207570CompletedPhase 2

Effect of Endermotherapy on Passive Ankle Range of Motion in Children With Developmental Disabilities

The Hong Kong Polytechnic University1 site in 1 country54 target enrollmentStarted: February 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
54
Locations
1
Primary Endpoint
Ankle Passive Range of Motion

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •children aged between 2 and
  • •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

Arms & Interventions

Endermotherapy

Experimental

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.

Intervention: Endermotherapy (Procedure)

Passive stretching

Active Comparator

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

Intervention: Passive manual stretching (Procedure)

Outcomes

Primary Outcomes

Ankle Passive Range of Motion

Time Frame: Day 4 after treatment

Ankle passive range of motion on day 4 after the crossover treatment

Ankle Passive Range of Motion

Time Frame: day 1 before treatment

The ankle passive range of motion will be measured by a Myrin goniometer.

Ankle Passive Range of Motion

Time Frame: day 4 before treatment

Ankle passive range of motion at day 4 before the crossover treatment

Ankle Passive Range of Motion

Time Frame: Day 1 after treatment

Ankle dorsiflexion passive range of motion

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marco Yiu-Chung Pang

Associate Professor

The Hong Kong Polytechnic University

Study Sites (1)

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