Biofeedback to Increase Propulsion During Walking After Stroke
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 11/24/2018 |
| Start Date: | October 2, 2017 |
| End Date: | January 31, 2019 |
| Contact: | Dorian K Rose, PhD MS BS |
| Email: | Dorian.Rose@va.gov |
| Phone: | (352) 273-8307 |
Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an
estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88
million for follow-up care over 6 months post-stroke. Rehabilitation of walking ability
contributes to these costs. To "walk again" is the number one stated goal for Veterans who
have had a stroke. Teaching patients post-stroke to use their weak leg while they are
regaining walking function and to not compensate by over-using their strong leg is necessary
to restore safe, efficient walking ability. This project will determine if providing
biofeedback (an audible tone) from pressure-sensitive shoe insole sensors, that encourage use
of the weaker leg during walking training, in addition to therapists' feedback, will help
Veterans regain use of their weak leg, improve their endurance and improve their balance when
walking in challenging environments.
estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88
million for follow-up care over 6 months post-stroke. Rehabilitation of walking ability
contributes to these costs. To "walk again" is the number one stated goal for Veterans who
have had a stroke. Teaching patients post-stroke to use their weak leg while they are
regaining walking function and to not compensate by over-using their strong leg is necessary
to restore safe, efficient walking ability. This project will determine if providing
biofeedback (an audible tone) from pressure-sensitive shoe insole sensors, that encourage use
of the weaker leg during walking training, in addition to therapists' feedback, will help
Veterans regain use of their weak leg, improve their endurance and improve their balance when
walking in challenging environments.
Background/Purpose: Approximately 15,000 Veterans are hospitalized for stroke each year.
Impairments of motor control and the subsequent functional limitations in ambulation are the
most common manifestations and regaining the ability to walk is the number one stated goal of
Veteran stroke survivors. Forward propulsion of the body's center of mass is a cardinal
feature of gait that depends on the generation of appropriate anterior-posterior ground
reaction forces. Decreased propulsive force generation by the paretic limb of stroke
survivors has been identified through both simulation and cross-sectional studies as a major
contributor to walking dysfunction. Extrinsic verbal feedback from a therapist is the
standard approach used during gait retraining to improve propulsion generation. However, this
key component of gait is not directly observable by therapists and patients are often unable
to sense propulsion generation due to impaired intrinsic feedback, specifically deficits in
somatosensation and proprioception, hindering recovery of paretic propulsion and compromising
walking function. The objective of this study is to provide preliminary evidence that
biofeedback as an adjuvant to therapists' verbal feedback will improve propulsion and enhance
walking function for Veterans post-stroke.
Subjects: Thirty individuals > 6-months post-stroke will participate. Additional study
criteria include: 1) Ambulation of household distances without physical assistance to advance
or support the paretic leg; 2) Unilateral leg paresis confirmed by a score of < 32 on the
Fugl-Meyer Motor Assessment; 3) Step length asymmetry (paretic > non-paretic step length); 4)
Ambulation without an assistive or orthotic device.
Methods: Participants will be randomized to either an experimental group that will train with
propulsion biofeedback from commercially available pressure-sensitive insole sensors
(Biofeedback group; n=15) or a control group that will train with standard therapist-provided
verbal feedback alone (Standard group; n=15). The 12 session (3X/week for 4 weeks) gait
training intervention will be delivered by a physical therapist-led team. For participants in
the Biofeedback group, prior to the first intervention session, the baseline amount of
pressure exerted by the paretic forefoot during late stance will be determined. The insole
area underlying the forefoot will then be calibrated to produce a tone when pressure exceeds
5% of this baseline pressure. This threshold will be progressively increased at regular
intervals throughout the intervention period to ensure participants are training at their
challenge-point to improve propulsion of the paretic limb. An insole of similar thickness
will be worn in the shoe of the non-paretic leg for symmetry and comfort but will not produce
a tone during the intervention. Those in the Standard group will not wear insoles during
intervention but will receive verbal feedback alone regarding propulsion of the paretic limb
during gait training. Therapist-provided verbal feedback will be used to instruct
participants on achieving and/or maintaining appropriate movement patterns that contribute to
propulsion generation. For both groups, the therapist will choose from a standardized bank of
gait activities, suitable to each participant's ability level. The goal for total walking
time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between
each bout.
Outcome Measures: Paretic limb propulsion is the primary outcome measure. Secondary measures
include the Six Minute Walk Test, Functional Gait Assessment, Fall Self-Efficacy,
temporal-distance gait measures and gait kinematics, all of which will be measured pre- and
post-intervention.
Data Analysis Plan: Descriptive statistics will be provided for all outcome measures. To
identify the effect of the intervention, differences between the pre- and post-training
assessment within each group (i.e. change scores) will be calculated. To test the hypotheses,
the investigators will apply independent sample t-tests to the change scores of the
Biofeedback and Standard group. Hypothesis testing will be conducted at a two-sided p < 0.05
level.
Impairments of motor control and the subsequent functional limitations in ambulation are the
most common manifestations and regaining the ability to walk is the number one stated goal of
Veteran stroke survivors. Forward propulsion of the body's center of mass is a cardinal
feature of gait that depends on the generation of appropriate anterior-posterior ground
reaction forces. Decreased propulsive force generation by the paretic limb of stroke
survivors has been identified through both simulation and cross-sectional studies as a major
contributor to walking dysfunction. Extrinsic verbal feedback from a therapist is the
standard approach used during gait retraining to improve propulsion generation. However, this
key component of gait is not directly observable by therapists and patients are often unable
to sense propulsion generation due to impaired intrinsic feedback, specifically deficits in
somatosensation and proprioception, hindering recovery of paretic propulsion and compromising
walking function. The objective of this study is to provide preliminary evidence that
biofeedback as an adjuvant to therapists' verbal feedback will improve propulsion and enhance
walking function for Veterans post-stroke.
Subjects: Thirty individuals > 6-months post-stroke will participate. Additional study
criteria include: 1) Ambulation of household distances without physical assistance to advance
or support the paretic leg; 2) Unilateral leg paresis confirmed by a score of < 32 on the
Fugl-Meyer Motor Assessment; 3) Step length asymmetry (paretic > non-paretic step length); 4)
Ambulation without an assistive or orthotic device.
Methods: Participants will be randomized to either an experimental group that will train with
propulsion biofeedback from commercially available pressure-sensitive insole sensors
(Biofeedback group; n=15) or a control group that will train with standard therapist-provided
verbal feedback alone (Standard group; n=15). The 12 session (3X/week for 4 weeks) gait
training intervention will be delivered by a physical therapist-led team. For participants in
the Biofeedback group, prior to the first intervention session, the baseline amount of
pressure exerted by the paretic forefoot during late stance will be determined. The insole
area underlying the forefoot will then be calibrated to produce a tone when pressure exceeds
5% of this baseline pressure. This threshold will be progressively increased at regular
intervals throughout the intervention period to ensure participants are training at their
challenge-point to improve propulsion of the paretic limb. An insole of similar thickness
will be worn in the shoe of the non-paretic leg for symmetry and comfort but will not produce
a tone during the intervention. Those in the Standard group will not wear insoles during
intervention but will receive verbal feedback alone regarding propulsion of the paretic limb
during gait training. Therapist-provided verbal feedback will be used to instruct
participants on achieving and/or maintaining appropriate movement patterns that contribute to
propulsion generation. For both groups, the therapist will choose from a standardized bank of
gait activities, suitable to each participant's ability level. The goal for total walking
time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between
each bout.
Outcome Measures: Paretic limb propulsion is the primary outcome measure. Secondary measures
include the Six Minute Walk Test, Functional Gait Assessment, Fall Self-Efficacy,
temporal-distance gait measures and gait kinematics, all of which will be measured pre- and
post-intervention.
Data Analysis Plan: Descriptive statistics will be provided for all outcome measures. To
identify the effect of the intervention, differences between the pre- and post-training
assessment within each group (i.e. change scores) will be calculated. To test the hypotheses,
the investigators will apply independent sample t-tests to the change scores of the
Biofeedback and Standard group. Hypothesis testing will be conducted at a two-sided p < 0.05
level.
Inclusion Criteria:
- Diagnosis of stroke
- > 6 months < 5 years post-stroke onset
- Medically stable
- 18-80 years of age
- Impaired lower extremity sensation confirmed by a score of < 12 on the Fugl-Meyer
Sensory Assessment,20
- Community-dwelling
- Step length asymmetry (paretic step length > non-paretic step length)
- this asymmetry has been determined to be correlated with minimal propulsive force
of the paretic leg4
- Unilateral lower extremity paresis confirmed by a score of < 32 on the Fugl-Meyer
Motor Assessment,20
- Able to ambulate without an orthotic device
- Able to ambulate without an assistive device
- Ambulation of household distances without physical assistance to advance or support
paretic lower extremity
Exclusion Criteria:
- Presence of a neurological condition other than stroke
- Pain upon ambulation
- Receiving physical therapy services for mobility and/or gait
- Severe arthritis or orthopedic problems that limit passive ranges of motion
- knee flexion contracture of -10 , knee flexion range of motion (ROM) < 90
- hip flexion contracture > 25
- ankle plantar flexion contracture > 15
We found this trial at
1
site
Gainesville, Florida 32608
Principal Investigator: Dorian Kay Rose, PhD MS BS
Phone: (352) 376-1611
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