A Phase 2 interventional study of Endermotherapy and Passive manual stretching in Cerebral Palsy and Developmental Delay, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2011-10-10.
Sponsored by The Hong Kong Polytechnic University · Phase 2, Interventional, and Treatment
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.
1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.
This study's enrollment of 54 is above the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.
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Exclusion Criteria:
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
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
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.
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.
Ankle Passive Range of Motion
The ankle passive range of motion will be measured by a Myrin goniometer.
Time frame: day 1 before treatment
Ankle Passive Range of Motion
Ankle passive range of motion at day 4 before the crossover treatment
Time frame: day 4 before treatment
Ankle Passive Range of Motion
Ankle dorsiflexion passive range of motion
Time frame: Day 1 after treatment
Ankle Passive Range of Motion
Ankle passive range of motion on day 4 after the crossover treatment
Time frame: Day 4 after treatment
The subjects were recruited from Heep Hong Society, a non-governmental organization that provides rehabilitation services for children with disabilities. The recruitment period was between January 2010 and June 2010.
| Milestone | Endermotherapy | Passive Stretching |
|---|---|---|
| Started | 23 | 31 |
| Completed | 23 | 31 |
| Not completed | 0 | 0 |
| Milestone | Endermotherapy | Passive Stretching |
|---|---|---|
| Started | 31 | 23 |
| Completed | 31 | 23 |
| Not completed | 0 | 0 |
The ankle passive range of motion will be measured by a Myrin goniometer.
| degree | Endermotherapy | Passive Stretching |
|---|---|---|
| Ankle Passive Range of Motion | 8.3 ± 8.1 | 10.4 ± 6.0 |
Ankle passive range of motion at day 4 before the crossover treatment
| degree | Endermotherapy | Passive Stretching |
|---|---|---|
| Ankle Passive Range of Motion | 11.6 ± 6.0 | 11.3 ± 8.3 |
Ankle dorsiflexion passive range of motion
| degree | Endermotherapy | Passive Stretching |
|---|---|---|
| Ankle Passive Range of Motion | 12.2 ± 8.6 | 14.9 ± 6.7 |
Ankle passive range of motion on day 4 after the crossover treatment
| degree | Endermotherapy | Passive Stretching |
|---|---|---|
| Ankle Passive Range of Motion | 15.9 ± 6.7 | 13.5 ± 8.4 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Endermotherapy | — | 0/54 (0%) | 0/54 (0%) |
| Passive Stretching | — | 0/54 (0%) | 0/54 (0%) |
| Age, Categorical(Participants) | Endermotherapy | Passive Stretching | Total |
|---|---|---|---|
| <=18 years | 23 | 31 | 54 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Endermotherapy | Passive Stretching | Total |
|---|---|---|---|
| Mean | 4.7 ± 1.5 | 4.9 ± 1.2 | 4.8 ± 1.3 |
| Sex: Female, Male(Participants) | Endermotherapy | Passive Stretching | Total |
|---|---|---|---|
| Female | 7 | 15 | 22 |
| Male | 16 | 16 | 32 |
| Region of Enrollment(participants) | Endermotherapy | Passive Stretching | Total |
|---|---|---|---|
| Hong Kong | 23 | 31 | 54 |
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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The Hong Kong Polytechnic University