Phase 2
N=54
Endermotherapy for Children With Developmental Disabilities
Cerebral Palsy · Developmental Delay
Bottom Line
View on ClinicalTrials.gov: NCT01207570 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcome: Primary: Ankle Passive Range of Motion — 8.3; 10.4 degree
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Endermotherapy (Procedure); Passive manual stretching (Procedure)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- The Hong Kong Polytechnic University
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ankle Passive Range of Motion |
15.9; 13.5 | — |
| PRIMARY Ankle Passive Range of Motion |
15.9; 13.5 | — |
| PRIMARY Ankle Passive Range of Motion |
15.9; 13.5 | — |
| PRIMARY Ankle Passive Range of Motion |
15.9; 13.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01207570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.