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Walk Assist Device to Improve Community Ambulation

15 agosto 2019 aggiornato da: Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab

Development of Walk Assist Device to Improve Community Ambulation

The goal of this research study was to examine the immediate effects of a prototype wearable robotic stride management assist device (SMA) designed by Honda R&D® on clinical walking performance, walking energetics, gait kinematics and corticospinal excitability in individuals with stroke.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

The goal of this research study was to examine the immediate effectiveness of a prototype wearable robotic stride management assist device (SMA) designed by Honda R&D on clinical walking performance, walking energetics, gait kinematics and corticospinal excitability in individuals with stroke.

The SMA assists walking by providing a flexion and extension torque assist at the hip joint. The subjects in this study are asked to perform two sets of experiments: one set with the device on and one set with the device turned off. The order in which the subjects performed these sets of experiments is selected randomly. Each set of experiments includes over-ground walking speed and endurance tests, a graded treadmill test with metabolic measures, motion capture and force treadmill analysis, and measures of corticospinal drive using transcranial magnetic stimulation (TMS). The primary outcome to be measured is change in self-selected walking speed with the device on, the secondary outcome measures include metabolic, corticospinal and biomechanical analysis.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

12

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Illinois
      • Chicago, Illinois, Stati Uniti, 60611
        • Rehabilitation Institute of Chicago

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Stroke subjects with a history of unilateral, supratentorial, ischemic or hemorrhage stroke will be recruited, with lesion location confirmed by radiographic findings.
  2. All subjects who score > 10 on the Lower Extremity Motor Score (LEMS) developed previously to measure strength in Spinal Cord Injury (SCI). For the LEMS criteria, preliminary data indicate that subjects with LEMS < 10 in the chronic stages do not recover walking.
  3. All subjects will be required to walk > 10 m over ground without physical assistance at self-selected walking speeds ≤ 0.8 m/s using assistive devices and bracing below the knee as needed. A criterion of 0.8 m/s is utilized to target participants with limited or minimal ambulation in the community. Subjects will be further stratified into those who walk < 0.4 m/s and > 0.4 m/s, identified as household vs. limited community ambulators, respectively.
  4. Range of motion (ankle: -10 to 30 deg, knee: 0 to 90 deg, hip: -10 to 40 deg) consistent with gait;
  5. Medically stable with medical clearance to participate (absence of concurrent illness, including unhealed decubiti, infection, cardiopulmonary disease, osteoporosis, active heterotrophic ossification or peripheral nerve damage in the lower limbs, history of traumatic head injury);
  6. Able to tolerate 30 minutes of upright (standing) position without orthostasis (decrease in blood pressure by 20 mmHg systolic and 10 mmHg diastolic; minimized with ambulatory population);
  7. Must not be undergoing concurrent physical therapy to eliminate effects of additional interventions;
  8. Patients prescribed medications for spasticity will not be excluded from participation but will be asked to maintain current levels of medication or inform the researcher if changes are necessary.

    -

Exclusion Criteria:

  1. Women of childbearing potential will not be excluded, although women who are pregnant will be excluded due to potential forces at trunk from body weight support or pelvic assistance;
  2. Significant cardiorespiratory or metabolic disease that may limit exercise participation.
  3. Weights limit > 250 lbs (limit of most counter-weight safety systems).
  4. History of previous orthopedic or neurological conditions which may impair walking.
  5. Exclusion for 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, and pregnancy.
  6. Subjects with scores < 23 on the Mini Mental Status Exam will be excluded.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Treadmill
Subjects performed assessments of walking and motor performance while wearing the Honda Stride Assist Device.
Subjects performed assessments of walking and motor performance without wearing the Honda Assist Device.
Sperimentale: Overground Walking
Subjects performed assessments of walking and motor performance while wearing the Honda Stride Assist Device.
Subjects performed assessments of walking and motor performance without wearing the Honda Assist Device.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Six Minute Walk Test Between Device Turned ON and OFF - Distance Traveled
Lasso di tempo: Day 1
The 6 Minute Walk Test (6MWT) is a test of endurance, by measuring the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary.The distance is measured with a measuring wheel. The instructions are "Walk covering as much ground as you can in 6 min. You can stop to sit or stand if needed."
Day 1
Change in Peak Treadmill (TM) Velocity Between Device Turned ON and OFF - Self Selected Walking Speed
Lasso di tempo: Day 1
Peak treadmill (TM) velocity: subjects walked on motorized treadmill with harness but no Body Weight Support (BWS). Testing started at 0.5 km/h and was increased in 0.5 km/h increments every 3 minutes until peak TM speed was achieved (identified as ability to sustain speed for ≥1min without stopping the treadmill).
Day 1

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent Change in Excitability of Transcranial Magnetic Stimulation (TMS) Rectus Femoris (RF) Between Device ON and Device OFF
Lasso di tempo: Day 1
TMS measurements will involve generating motor evoked potentials (MEP) for each muscle from two different coil positions - 2cm on either side of the vertex. Motor evoked potentials (MEPs) at intensities ranging from 70 - 140% active threshold will be generated for each muscle from each coil position. TMS is a safe, non-invasive, painless method of brain stimulation that has been widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals. A positive percent change in excitability indicates higher excitability in the device-on condition. A negative percent change in excitability indicates higher excitability in the device-off condition.
Day 1
Change in Percent Excitability of Transcranial Magnetic Stimulation (TMS), Dorsiflexor Tibialis Anterior (TA) Between Device ON and Device OFF
Lasso di tempo: Day 1
TMS measurements will involve generating motor evoked potentials (MEP) for each muscle from two different coil positions - 2cm on either side of the vertex. Motor evoked potentials (MEPs) at intensities ranging from 70 - 140% active threshold will be generated for each muscle from each coil position. TMS is a safe, non-invasive, painless method of brain stimulation that has been widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals. A positive percent change in excitability indicates higher excitability in the device-on condition. A negative percent change in excitability indicates higher excitability in the device-off condition.
Day 1

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2010

Completamento primario (Effettivo)

1 maggio 2018

Completamento dello studio (Effettivo)

1 maggio 2018

Date di iscrizione allo studio

Primo inviato

22 giugno 2017

Primo inviato che soddisfa i criteri di controllo qualità

18 luglio 2017

Primo Inserito (Effettivo)

19 luglio 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 agosto 2019

Ultimo verificato

1 agosto 2019

Maggiori informazioni

Termini relativi a questo studio

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Honda Stride Assist Device ON

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