Trial Outcomes & Findings for Cross-Education Of Contralateral Antagonists (NCT NCT01103232)

Last Updated: 2012-06-25

Results Overview

Isokinetic torque was measured in the contralateral untrained wrist muscles with the Cybex (Humac 2004/Norm) extremity-testing system before and after experiment.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

6 weeks (The change calculated as 6 months minus baseline)

Results posted on

2012-06-25

Participant Flow

All cases were recruited within 6 weeks in the VGEAH PMR Clinic

Participant milestones

Participant milestones
Measure	Experimental Electrical muscle stimulation of the right wrist flexor muscles was applied	Control Transcutaneous electrical nerve stimulation was applied
Overall Study STARTED	13	13
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Electrical muscle stimulation of the right wrist flexor muscles was applied	Control Transcutaneous electrical nerve stimulation was applied
Overall Study Withdrawal by Subject	1	1
Overall Study Protocol Violation	0	1

Baseline Characteristics

Cross-Education Of Contralateral Antagonists

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=13 Participants Electrical muscle stimulation of the right wrist flexor muscles was applied	Control n=13 Participants Transcutaneous electrical nerve stimulation was applied	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26 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	29.6 years STANDARD_DEVIATION 5.7 • n=5 Participants	34.2 years STANDARD_DEVIATION 4.8 • n=7 Participants	32 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Muscle strength	44.1 Newton meters STANDARD_DEVIATION 12.0 • n=5 Participants	11.7 Newton meters STANDARD_DEVIATION 6.3 • n=7 Participants	33.2 Newton meters STANDARD_DEVIATION 11.9 • n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks (The change calculated as 6 months minus baseline)

Isokinetic torque was measured in the contralateral untrained wrist muscles with the Cybex (Humac 2004/Norm) extremity-testing system before and after experiment.

Outcome measures

Outcome measures
Measure	Experimental n=13 Participants Electrical muscle stimulation of the right wrist flexor muscles was applied	Control n=13 Participants Transcutaneous electrical nerve stimulation was applied
Changes in Muscle Strength in the Contralateral Untrained Wrist Muscles	44.1 Newton meters Standard Deviation 12.0	11.7 Newton meters Standard Deviation 6.3

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

ILHAN KARACAN

Vakif Gureba Training and Research Hospital

Phone: + 90 212 4531700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place