Endermotherapy for Children With Developmental Disabilities

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207570
• Other study ID #: HSEARS20091207001
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2010
• Last updated: October 7, 2011
• Start date: February 2010
• Est. completion date: May 2011

Study information

• Verified date: October 2011
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Research Office,The Hong Kong Polytechnic University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Developmental Delay
• Developmental Disabilities

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	Heep Hong Society	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Phoelia Co. Ltd.

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle Passive Range of Motion	The ankle passive range of motion will be measured by a Myrin goniometer.	day 1 before treatment	No
Primary	Ankle Passive Range of Motion	Ankle passive range of motion at day 4 before the crossover treatment	day 4 before treatment	No
Primary	Ankle Passive Range of Motion	Ankle dorsiflexion passive range of motion	Day 1 after treatment	No
Primary	Ankle Passive Range of Motion	Ankle passive range of motion on day 4 after the crossover treatment	Day 4 after treatment	No