Trial Outcomes & Findings for Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise (NCT NCT01679600)

NCT ID: NCT01679600

Last Updated: 2015-08-05

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

4 weeks

Results posted on

2015-08-05

Participant Flow

6 subjects dropped out before assiggnment (abnormal gait pattern due to uncontrollable spasticity, tibia skin lesion due to inadequate padding during familiarization, lack of motivation to produce maximal work rate values, severe groin pain caused by the body weight support harness, suspected cerebrospinal fluid leak, acute respiratory infection)

Participant milestones

Participant milestones
Measure	FC-RATE Feedback-controlled robotics-assisted treadmill exercise Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate	RATE Robotics-assisted treadmill exercise Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise
Overall Study STARTED	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FC-RATE n=7 Participants Feedback-controlled robotics-assisted treadmill exercise Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate	RATE n=7 Participants Robotics-assisted treadmill exercise Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise	Total n=14 Participants Total of all reporting groups
Age, Continuous	57 years STANDARD_DEVIATION 12 • n=5 Participants	63 years STANDARD_DEVIATION 13 • n=7 Participants	61 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Switzerland	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Type of stroke: ischemic/hemorrhagic ischemic	5 participants n=5 Participants	7 participants n=7 Participants	12 participants n=5 Participants
Type of stroke: ischemic/hemorrhagic hemorrhagic	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Hemiparetic side: right/left right	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Hemiparetic side: right/left left	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants
Functional Ambulation Classification (0-5)	1 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants	0.9 units on a scale STANDARD_DEVIATION 1 • n=7 Participants	1 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants
Time poststroke	52 days STANDARD_DEVIATION 42 • n=5 Participants	45 days STANDARD_DEVIATION 30 • n=7 Participants	52 days STANDARD_DEVIATION 31 • n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	FC-RATE n=7 Participants Feedback-controlled robotics-assisted treadmill exercise Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate	RATE n=7 Participants Robotics-assisted treadmill exercise Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise
Peak Oxygen Uptake (V'O2peak)	1461 mL/min Standard Deviation 683	1494 mL/min Standard Deviation 672

Adverse Events

FC-RATE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RATE

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. Oliver Stoller

Bern University of Applied Sciences

Phone: +41344264195

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place