Cerebral Palsy, Developmental Delay
Conditions
Keywords
flexibility, muscle, stretching, cerebral palsy, developmental
Brief 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.
Interventions
PROCEDUREEndermotherapy
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.
PROCEDUREPassive 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.
Sponsors
Phoelia Co. Ltd.
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ankle Passive Range of Motion | day 1 before treatment | The ankle passive range of motion will be measured by a Myrin goniometer. |
Countries
Hong Kong
Participant flow
Recruitment details
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.
Pre-assignment details
No significant events.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| Passive Stretching The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes. | 31 |
| Total | 54 |
Baseline characteristics
| Characteristic | Passive Stretching | Endermotherapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 31 Participants | 23 Participants | 54 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 4.9 years STANDARD_DEVIATION 1.2 | 4.7 years STANDARD_DEVIATION 1.5 | 4.8 years STANDARD_DEVIATION 1.3 |
| Region of Enrollment Hong Kong | 31 participants | 23 participants | 54 participants |
| Sex: Female, Male Female | 15 Participants | 7 Participants | 22 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 | 0 / 54 |
Outcome results
Primary
Ankle Passive Range of Motion
The ankle passive range of motion will be measured by a Myrin goniometer.
Time frame: day 1 before treatment
Population: All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endermotherapy | Ankle Passive Range of Motion | 8.3 degree | Standard Deviation 8.1 |
| Passive Stretching | Ankle Passive Range of Motion | 10.4 degree | Standard Deviation 6 |
Primary
Ankle Passive Range of Motion
Ankle passive range of motion at day 4 before the crossover treatment
Time frame: day 4 before treatment
Population: All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endermotherapy | Ankle Passive Range of Motion | 11.6 degree | Standard Deviation 6 |
| Passive Stretching | Ankle Passive Range of Motion | 11.3 degree | Standard Deviation 8.3 |
Primary
Ankle Passive Range of Motion
Ankle dorsiflexion passive range of motion
Time frame: Day 1 after treatment
Population: All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endermotherapy | Ankle Passive Range of Motion | 12.2 degree | Standard Deviation 8.6 |
| Passive Stretching | Ankle Passive Range of Motion | 14.9 degree | Standard Deviation 6.7 |
Primary
Ankle Passive Range of Motion
Ankle passive range of motion on day 4 after the crossover treatment
Time frame: Day 4 after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endermotherapy | Ankle Passive Range of Motion | 15.9 degree | Standard Deviation 6.7 |
| Passive Stretching | Ankle Passive Range of Motion | 13.5 degree | Standard Deviation 8.4 |