Trial Outcomes & Findings for Endermotherapy for Children With Developmental Disabilities (NCT NCT01207570)

Results Overview

The ankle passive range of motion will be measured by a Myrin goniometer.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

day 1 before treatment

Results posted on

2011-10-10

Participant Flow

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.

No significant events.

Participant milestones

Participant milestones
Measure	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 The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
The First Stage (Before Crossover) STARTED	23	31
The First Stage (Before Crossover) COMPLETED	23	31
The First Stage (Before Crossover) NOT COMPLETED	0	0
The Second Stage (After Crossover) STARTED	31	23
The Second Stage (After Crossover) COMPLETED	31	23
The Second Stage (After Crossover) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Endermotherapy for Children With Developmental Disabilities

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Endermotherapy n=23 Participants 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 n=31 Participants The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	23 Participants n=5 Participants	31 Participants n=7 Participants	54 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	4.7 years STANDARD_DEVIATION 1.5 • n=5 Participants	4.9 years STANDARD_DEVIATION 1.2 • n=7 Participants	4.8 years STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	15 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment Hong Kong	23 participants n=5 Participants	31 participants n=7 Participants	54 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

The ankle passive range of motion will be measured by a Myrin goniometer.

Outcome measures

Outcome measures
Measure	Endermotherapy n=23 Participants A single endermotherapy treatment session	Passive Stretching n=31 Participants A single passive stretching session
Ankle Passive Range of Motion	8.3 degree Standard Deviation 8.1	10.4 degree Standard Deviation 6.0

PRIMARY outcome

Timeframe: 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.

Ankle passive range of motion at day 4 before the crossover treatment

Outcome measures

Outcome measures
Measure	Endermotherapy n=31 Participants A single endermotherapy treatment session	Passive Stretching n=23 Participants A single passive stretching session
Ankle Passive Range of Motion	11.6 degree Standard Deviation 6.0	11.3 degree Standard Deviation 8.3

PRIMARY outcome

Timeframe: 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.

Ankle dorsiflexion passive range of motion

Outcome measures

Outcome measures
Measure	Endermotherapy n=23 Participants A single endermotherapy treatment session	Passive Stretching n=31 Participants A single passive stretching session
Ankle Passive Range of Motion	12.2 degree Standard Deviation 8.6	14.9 degree Standard Deviation 6.7

PRIMARY outcome

Timeframe: Day 4 after treatment

Ankle passive range of motion on day 4 after the crossover treatment

Outcome measures

Outcome measures
Measure	Endermotherapy n=23 Participants A single endermotherapy treatment session	Passive Stretching n=31 Participants A single passive stretching session
Ankle Passive Range of Motion	15.9 degree Standard Deviation 6.7	13.5 degree Standard Deviation 8.4

Adverse Events

Endermotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Passive Stretching

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marco Pang

The Hong Kong Polytechnic University

Phone: 85227667156

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place