Trial Outcomes & Findings for Locomotor Training (Walking Therapy) Post Stroke (NCT NCT00715299)

NCT ID: NCT00715299

Last Updated: 2015-03-05

Results Overview

Walking speed is a continuous measure descriptive of overall ambulatory function. This is easily captured with a pressure-sensitive walkway. Three of the 30 participants who completed the study had incomplete data sets, so outcomes are reported on an n=27.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: Pre and post Treatment
• Results posted on: 2015-03-05

Participant Flow

Participant milestones

Measure	Total Locomotor Training Group persons who have sustained a stroke within greater than 6 months ago and less than 5 years. locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern.
Overall Study STARTED	36
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Total Locomotor Training Group persons who have sustained a stroke within greater than 6 months ago and less than 5 years. locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern.
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	3
Overall Study failed the pre-screen exercise test	2

Baseline Characteristics

Locomotor Training (Walking Therapy) Post Stroke

Baseline characteristics by cohort

Measure	Arm 1 n=36 Participants persons who have sustained a stroke within greater than 6 months ago and less than 5 years. locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	58.7 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre and post Treatment

Walking speed is a continuous measure descriptive of overall ambulatory function. This is easily captured with a pressure-sensitive walkway. Three of the 30 participants who completed the study had incomplete data sets, so outcomes are reported on an n=27.

Outcome measures

Measure

Locomotor Training Group n=27 Participants persons who have sustained a stroke within greater than 6 months ago and less than 5 years. locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern. 18 responded with a walking speed greater than 0.16 m/s, while 9 has a change \< 0.16 m/s.

The Primary Outcome Measure Was Pre-treatment to Post-treatment Change in Self-selected Walking Speed.

0.21 meters per second Standard Deviation 0.13

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm 1 n=36 participants at risk persons who have sustained a stroke within greater than 6 months ago and less than 5 years. locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern.
Cardiac disorders Failed exercise tolerance test	5.6% 2/36 • Number of events 2
Cardiac disorders Abnormal response to exercise	5.6% 2/36 • Number of events 2
General disorders Patient complaints of gout flare up	2.8% 1/36 • Number of events 1

Additional Information

Steve Kautz, PhD, Principal Investigator

VAHSRD and Medical University of South Carolina

Phone: 843-792-3867

Email: kautz@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place