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| Name | Class |
|---|---|
| Phoelia Co. Ltd. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Y P, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heep Hong Society | Hong Kong | Hong Kong |
No significant events.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Passive Stretching | The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| The First Stage (Before Crossover) |
| |||||||||||||
| The Second Stage (After Crossover) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Passive Stretching |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ankle Passive Range of Motion | The ankle passive range of motion will be measured by a Myrin goniometer. | All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data. | Posted | Mean | Standard Deviation | degree | day 1 before treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marco Pang | The Hong Kong Polytechnic University | 85227667156 | Marco.Pang@inet.polyu.edu.hk |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
|
| NOT COMPLETED |
|
The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Ankle Passive Range of Motion | Ankle passive range of motion at day 4 before the crossover treatment | All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data. | Posted | Mean | Standard Deviation | degree | day 4 before treatment |
|
|
|
| Primary | Ankle Passive Range of Motion | Ankle dorsiflexion passive range of motion | All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data. | Posted | Mean | Standard Deviation | degree | Day 1 after treatment |
|
|
|
| Primary | Ankle Passive Range of Motion | Ankle passive range of motion on day 4 after the crossover treatment | Posted | Mean | Standard Deviation | degree | Day 4 after treatment |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Passive Stretching | The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes. | 0 | 54 | 0 | 54 |
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| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |