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OpenTrials
Completed

NCT Number: NCT01207570

Endermotherapy for 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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Communication Disorders Developmental Delay Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Heep Hong Society

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endermotherapy

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 manual stretching

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.

Primary outcomes

  1. Ankle Passive Range of Motion

    Time frame: day 1 before treatment

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

  2. Ankle Passive Range of Motion

    Time frame: day 4 before treatment

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

  3. Ankle Passive Range of Motion

    Time frame: Day 1 after treatment

    Ankle dorsiflexion passive range of motion

  4. Ankle Passive Range of Motion

    Time frame: Day 4 after treatment

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

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Phoelia Co. Ltd.

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 23, 2010
Registry last updated
Oct 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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