Effect of Endermotherapy on Passive Ankle Range of Motion in Children With Developmental Disabilities
| Registry | NCT01207570 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, crossover, masking: single, treatment |
| Enrollment | 54 (Actual) |
| Sponsor | The Hong Kong Polytechnic University (Other); collaborators: Phoelia Co. Ltd. |
| Conditions | Cerebral Palsy, Developmental Delay |
| Interventions | Endermotherapy, Passive manual stretching (Procedure) |
| Dates | start 2010-02-01, primary completion 2011-05-01, completion 2011-05-01, first posted 2010-09-23, last updated 2011-10-10 |
| Locations | 1 site in Hong Kong |
Related Papers Related Patents Related Grants Related Experts
All trials for Cerebral Palsy All trials for Developmental Delay All trials of Endermotherapy All trials of Passive manual stretching
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Endermotherapy | Experimental | Procedure: Endermotherapy | 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. |
| Passive stretching | Active comparator | Procedure: Passive manual stretching | The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes. |
Sex: All, ages: 2 Years to 6 Years
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
| Milestone | Endermotherapy | Passive Stretching |
|---|---|---|
| Started | 23 | 31 |
| Completed | 23 | 31 |
| Not completed | 0 | 0 |
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Endermotherapy | 0 | 0/54 (0.0%) | 0/54 (0.0%) |
| Passive Stretching | 0 | 0/54 (0.0%) | 0/54 (0.0%) |
| Facility | City | Country | Status |
|---|---|---|---|
| Heep Hong Society | Hong Kong | Hong Kong |