Journal Club CEU Approval
Contact Hours: 1
AR | FL CE26-803266 | ID
Body-Weight–Supported Treadmill Rehabilitation after Stroke
JC11Q3
On-demand
$10
On-demand
$10
Webinar Description
Summary by Nechama Karman, PT, MS, PCS
The LEAPS trial was a single-blind multi-site RCT comparing Locomotor Training (LT) with body-weight support to a specific home exercise program (HEP) implemented by a physical therapist in people with moderate to severe walking impairment post-stroke. It also compared early-delivered (2 months post-stroke) to late LT (6 months post-stroke) to determine whether timing of implementation has an impact on outcomes at 1 year post-stroke.
The LT protocol included a high intensity, task-specific walking program that targeted walking speed, with manual assistance for stepping; it included a target of 20-30 minutes of stepping practice at 2 mph on the treadmill with BWS using a Robomedica BWS system with Robertson harness and Biodex treadmill, followed by 15 minutes over-ground walking practice in each session. The HEP was designed to serve as an active control, and included exercises targeting flexibility, ROM, UE and LE strength, coordination, and static and dynamic balance training. Subjects (n=408) were evaluated for inclusion at 2 months post-stroke, and if they met criteria (primarily walking speed < .8 m/s) they were randomly assigned to one of 3 groups: early LT, late LT and HEP (with further stratification of moderate impairment- walking speed .4-.8 m/s and severe impairment < .4 m/s). Intervention included between 30-36 PT sessions of 90 minutes duration, delivered 3x/week over a 12-16 week intervention period. The primary outcome measure was the proportion of subjects in each group that improved their walking outcome (speed) by 1 year post-stroke, as measured with a 10 meter walk test (specifically looking for an increase in category of walking speed, i.e. above .4 m/s for severely impaired, and .8 m/s for moderately impaired participants). 52% of participants had improved walking ability (higher category, i.e. from household to limited community ambulation, or from limited to full community ambulation) at one year, with no significant difference between groups. Secondary outcomes included comfortable walking speed (CWS, 6MWT), motor recovery (LE Fugl Meyer), balance (Berg Balance Scale, ABC), functional status (ADL scale, SIS physical mobility) and quality of life (SIS participation) and subjective reporting of falls. Evaluations were blinded, and performed at 6 months post-stroke (post-intervention for the early LT group and the HEP group, pre-intervention for the late LT group), and at 1 year post-stroke (post-intervention for all groups). Dropout rates were 3% for the HEP group, and 13% (early) and 17% (late) for the LT groups. The changes in CWS were clinically meaningful for all groups (ELT .23 + .20 m/s; HEP .25 + .22 m/s; LLT .24 + .23 m/s) but variance was high. Changes in distance walked and steps taken in the community were clinically meaningful for all groups, as were improvements in balance, ADL, physical mobility and social participation, with modest changes in the Fugl-Meyer LE Motor Recovery scores. Baseline function (moderate vs. severe impairment in walking ability) did not seem to have an effect on outcomes, and neither did timing of delivery intervention. Gains were maintained at one year. The difference in outcomes between treatment groups (early LT and HEP) and non-treatment (late LT) at 6 months indicates that intervention promotes recovery (early intervention accelerated recovery), and that “more treatment” is more effective, as most participants did receive “usual” physical therapy during the study period (in addition to study interventions), primarily during the “early” intervention phase..
CEU Information
Overview
The LT protocol included a high intensity, task-specific walking program that targeted walking speed, with manual assistance for stepping; it included a target of 20-30 minutes of stepping practice at 2 mph on the treadmill with BWS using a Robomedica BWS system with Robertson harness and Biodex treadmill, followed by 15 minutes over-ground walking practice in each session. The HEP was designed to serve as an active control, and included exercises targeting flexibility, ROM, UE and LE strength, coordination, and static and dynamic balance training. Subjects (n=408) were evaluated for inclusion at 2 months post-stroke, and if they met criteria (primarily walking speed < .8 m/s) they were randomly assigned to one of 3 groups: early LT, late LT and HEP (with further stratification of moderate impairment- walking speed .4-.8 m/s and severe impairment < .4 m/s). Intervention included between 30-36 PT sessions of 90 minutes duration, delivered 3x/week over a 12-16 week intervention period. The primary outcome measure was the proportion of subjects in each group that improved their walking outcome (speed) by 1 year post-stroke, as measured with a 10 meter walk test (specifically looking for an increase in category of walking speed, i.e. above .4 m/s for severely impaired, and .8 m/s for moderately impaired participants). 52% of participants had improved walking ability (higher category, i.e. from household to limited community ambulation, or from limited to full community ambulation) at one year, with no significant difference between groups. Secondary outcomes included comfortable walking speed (CWS, 6MWT), motor recovery (LE Fugl Meyer), balance (Berg Balance Scale, ABC), functional status (ADL scale, SIS physical mobility) and quality of life (SIS participation) and subjective reporting of falls. Evaluations were blinded, and performed at 6 months post-stroke (post-intervention for the early LT group and the HEP group, pre-intervention for the late LT group), and at 1 year post-stroke (post-intervention for all groups). Dropout rates were 3% for the HEP group, and 13% (early) and 17% (late) for the LT groups. The changes in CWS were clinically meaningful for all groups (ELT .23 + .20 m/s; HEP .25 + .22 m/s; LLT .24 + .23 m/s) but variance was high. Changes in distance walked and steps taken in the community were clinically meaningful for all groups, as were improvements in balance, ADL, physical mobility and social participation, with modest changes in the Fugl-Meyer LE Motor Recovery scores. Baseline function (moderate vs. severe impairment in walking ability) did not seem to have an effect on outcomes, and neither did timing of delivery intervention. Gains were maintained at one year. The difference in outcomes between treatment groups (early LT and HEP) and non-treatment (late LT) at 6 months indicates that intervention promotes recovery (early intervention accelerated recovery), and that “more treatment” is more effective, as most participants did receive “usual” physical therapy during the study period (in addition to study interventions), primarily during the “early” intervention phase. Finally, the authors conclude that home exercise is a more pragmatic form of therapy post-stroke, arguing that the cost of commercial lifts is a barrier to use of the intervention, making the HEP intervention more feasible. They do not, however, consider the time commitment of a clinician travelling to a client’s home, and providing 90 minutes of specific exercise in a session. While the “session time” in therapy was longer for the LT groups (ELT: 83 + 6 min ; LLT 82 + 5 min; HEP 76 + 10 min), the actual treatment time (22 + 5 min TM stepping, 15.5 + 4.1 min overground walking) was significantly shorter than the session time, and “down-time” in clinic could be used effectively by the treating clinician, whereas a therapist in the patient’s home could not see another client while one is resting. Additionally, time spent by a physical therapist at a home visit may not be billable for the full 90 minutes, or for travel time. This added cost might ultimately negate the additive cost of equipment used for BWS gait training in a clinic, where multiple patients would benefit from its use.
Webinar Information
Contact Hours: 1
Price: $10
Instructor: Nechama Karman
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