Endermotherapy for Children With Developmental Disabilities

NCT01207570 | Completed Phase 2 Results DMC

• 1 other identifier: HSEARS20091207001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Developmental Delay

Keywords

flexibility; muscle; stretching; cerebral palsy; developmental

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Procedure: Endermotherapy

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.

Procedure: Passive manual stretching

Interventions

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.

Endermotherapy

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.

Passive stretching

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Other serious illnesses that preclude participation

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Phoelia Co. Ltd.: collaborator

Study Sites (1)

Heep Hong Society

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Cerebral Palsy; Learning Disabilities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Marco Pang
• Organization: The Hong Kong Polytechnic University

Marco.Pang@inet.polyu.edu.hk

85227667156

Study Officials

• Marco Y P, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 23, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 10, 2011
• Results First Posted: September 13, 2011

Record last verified: 2011-10

Locations

HK (1)