- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02483676
Ankle Robot to Reduce Foot Drop in Stroke
Adaptive Ankle Robot Control System to Reduce Foot-drop in Chronic Stroke
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
This proposal investigates a novel ankle robot (anklebot) adaptive control approach integrated with treadmill training to reduce foot drop and improve mobility function in chronic hemiparetic stroke survivors. Currently, stroke survivors with foot drop are trained to live with a cane or other assistive device, and often ankle foot orthotics (AFOs) for safety. Neither mediates task-practice or neuromotor recovery.
The investigators have developed an adaptive anklebot controller that detects gait cycle sub-events for precise timing of graded robotics assistance to enable deficit severity-adjusted ankle motor learning in the context of walking. The investigators' pilot findings show that 6 weeks treadmill training with anklebot (TMR) timed to assist swing phase dorsiflexion only is more effective than treadmill alone (TM) to improve free-walking swing dorsiflexion at foot strike, floor-walking speed, and the benefits are retained at 6 weeks post-training. Notably, swing-phase TMR training improved paretic leg push-off, and reduced center-of-pressure sway on standing balance, indicating potential benefits to other elements of gait and balance, beyond those robotically targeted toward foot drop.
This randomized study investigates the hypothesis that 6 weeks TMR is more effective to improve durably gait biomechanics, static, and dynamic balance, and mobility function in chronic stroke survivors with dorsiflexion deficits, compared to TM alone. Aims are to determine the compare effectiveness of 6 weeks TMR vs. TM alone on:
- Independent gait function indexed by gait velocity, swing-phase DF (dorsiflexion), terminal stance push-off.
- Balance function indexed by measures of postural sway (CoP), asymmetric loading in quiet standing, peak paretic A-P forces in non-paretic gait initiation, and standardized scales for balance and fall risk.
- Long-term mobility outcomes, assessed by repeated measures of all key gait and balance outcomes at 6 weeks and 3 months after formal training cessation.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Ischemic or hemorrhagic stroke > 2 months prior in men or women
- Residual hemiparesis of the lower extremity that includes symptoms of foot drop
- Capable of ambulating on a treadmill with handrail support
- Already completed all conventional physical therapy
- Adequate language and cognitive function to provide informed consent and participate in testing and training
Exclusion Criteria:
Cardiac history of:
- Unstable angina
- Recent (< 3 months) myocardial infarction
- Congestive heart failure (NYHA category II or higher)
- Hemodynamic valvular dysfunction
- Hypertension that is a contraindication for a bout of treadmill training (>160/100 mmHg on two assessments)
Medical history of:
- Recent hospitalization (< 3 months) for any serious condition leading to significant bed-rest or reduction in mobility function
- Symptomatic peripheral arterial occlusive disease
- Orthopedic or chronic pain conditions restricting exercise
- Pulmonary failure requiring oxygen
- Uncompensated renal failure
- Active cancer
Neurological history and exam consistent with:
- Dementia
- Receptive or global aphasia that confounds testing and training, operationally defined as unable to follow 2-point commands
- Non-stroke neurological disorder restricting exercise (e.g. Parkinson's Syndrome, myopathy)
- Untreated major depression
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Treadmill+anklebot
This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.
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This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.
Andre navne:
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Aktiv komparator: Treadmill only
This group will receive gait training on a treadmill, without use of the anklebot.
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This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Gait Velocity During Self-selected Overground Walking
Tidsramme: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Gait velocity during self-selected overground walking measured in cm/sec
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Anterior-posterior Propulsion Forces of Paretic Side During Gait
Tidsramme: Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months
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Newtons: anterior-posterior force generated during push-off phase of the gait cycle
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Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months
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Peak Dorsiflexion Angle During Swing Phase of Gait
Tidsramme: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Degrees; extent of ankle dorsiflexion to enable foot clearance
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Postural Sway Areas During Quiet Standing
Tidsramme: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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cm^2; extent of postural deviations to assess static postural control
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Ratio of Asymmetric Loading in Quiet Standing
Tidsramme: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Peak Paretic Push Off Forces During Gait Initiation
Tidsramme: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Newtons; magnitude of forward ground reaction forces
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Steven J Kittner, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- N1699-R
Plan for individuelle deltagerdata (IPD)
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