Very Intensive Early Walking in Stroke

Stroke Clinical Trial

— VIEWS  

Official title:

Improving the Delivery of Intensive Gait Training in the Clinical Setting to Augment Community Ambulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789853
• Other study ID #: STU00010421
• Status: Completed
• Phase: N/A
• First received: May 14, 2012
• Last updated: September 8, 2015
• Start date: October 2008
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Rehabilitation Institute of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the efficacy of intensive locomotor interventions early post stroke. An intensive locomotor training (LT) program will be compared to an active control, conventional physical therapy. It is proposed that an early and intensive stepping paradigm that is not typically employed early in physical therapy will lead to superior outcomes and improved community mobility. A randomized, blinded, controlled trial will test subjects with moderate to severe locomotor dysfunction in individuals post-stroke to compare walking-related outcomes after intensive gait training (including treadmill, overground, stair training, and skilled walking training) to outcomes after conventional physical therapy.

Description:

In Aim 2, intensive gait training overground and on the treadmill using the device as appropriate will be provided using a randomized, controlled trial (RCT) design. Determination of optimal swing phase and propulsive assistance provided to subjects to maximize treadmill walking velocity (in Aim 1) will be necessary to assess the efficacy of this technique to improve walking function over prolonged LT sessions. Consistent with work from the previous grant cycle12, we will compare the relative improvements in impairments, activity and participation following 1 of 2, 8 -week interventions to improve walking ability post-stroke. Fifty-six (56) subjects will be recruited, stratified based on walking 10 meters [requiring moderate assistance (subject performing 50-74%), minimal assistance (subject performing greater than 75% of gait but still needing assist), with a gait speed <0.5m/s without assist, or with gait speed of >0.5-0.9m/s without assist. Subjects will be randomized to experimental (intensive gait training using aforementioned gait training principles) or control conditions (conventional physical therapy). The test group will receive 40, 40-minute LT sessions during a 60 minute time period over 8 weeks with subjects ambulating on the treadmill, overground, and on stairs. During the first 5 training sessions, LT will take place solely on the treadmill. After that time, half of the sessions will be walking overground and stairs and half on the treadmill. Training will be performed with a target heart rate of 70-80% of heart rate reserve (HRR) and subjective ratings of perceived exertion of 14-17 when patients are on medications to limit heart rate kinetics. Kinematics during LT will be monitored visually to ensure proper foot placement necessary for continuous stepping while maintaining the appropriate intensity, using the device as necessary. The control group will receive conventional physical therapy (receiving at least 3 sessions of physical therapy per week) at the subject's and medical teams' discretion (day rehabilitation, outpatient, or home health). If the subject is not receiving at least 3 sessions of physical therapy per week, control therapy treatments will be provided consistent with recent data detailing the amount of specific physical therapy activities provided during single-session outpatient visits19and published data21 as well as unpublished data from Moore that delineates the number of steps taken per conventional therapy session based on the gait speed of individual (number of steps during training=1500*gait speed+200). The additional 200 steps were added to this algorithm to allow for individuals who require assist to receive gait training during the sessions. Clinical and quantitative assessment of neuromuscular and cardiopulmonary impairments, limitations in activity and participation, assessment of corticospinal tract (CST) excitability and integrity will be performed prior to training, mid-training, end of 8 week training, and with a 2-6 month follow-up examination. Control group participants will have the option of participating in 4 weeks of intensive gait training (experimental protocol) at the end of the follow up testing and complete one more testing session at the end of those 4 weeks. Primary outcome measures include laboratory and community measures of ambulatory function, including gait speed over short distances, distance walked and gait efficiency during the 6 min walk, and the amount of daily community stepping (using Step Activity Monitors [SAM]20), CST excitability measures using transcranial magnetic stimulation (TMS) (optional) and assessment of white matter tract integrity using MRI (optional).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• subacute (<6 months) stroke

• 18-75 years old

• history of history of unilateral, supratentorial, ischemic or hemorrhage stroke

• able to walk 10m without physical assistance

• gait speed less than or equal to .8m/s

• medical clearance

Exclusion Criteria:

• significant cardiorespiratory or metabolic disease that may limit exercise participation

• weight limit > 250 lbs (limit of most counter-weight safety systems)

• history of previous orthopedic or neurological conditions which may impair walking.

• women of childbearing potential will not be excluded, although women who are pregnant will be excluded due to potential forces at trunk from the harness applied at the waist.

• subjects with scores < 23 on the Mini Mental Status Exam

• Exclusion for transcranial magnetic stimulation (TMS):

• pacemaker

• metal implants in the head region

• history of epilepsy or seizures

• skull fractures or skull deficits

• concussion within the last 6 months

• unexplained recurring headaches

• medications that lower seizure threshold

• pregnancy

• Exclusion for the MRI:

• aneurysm clip or coil

• metal or wire implants

• heart valve prosthesis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Intensive Walking
8 weeks high intensity walking training over multiple stepping tasks
• Conventional Physical Therapy
Regular physical therapy for 8 weeks

Locations

Country	Name	City	State
United States	Rehabilitation Institute of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rehabilitation Institute of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 10 meter walk test	Gait speed	Pre Test, 4 weeks, 8 weeks, 3 month follow up	No
Secondary	Change in 6 min walk test	Timed walking distance over 6 min at self-selected speed	0, 4, 8 weeks post-training and 2 month follow-up	Yes
Secondary	Change in Berg Balance Scale	Standardized balance assessment	0. 4. 8 weeks post-training and 2 month follow-up	Yes