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Lo studio clinico NCT05218447 (DOOR SCI) per Lesioni del midollo spinale è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Dosing of Overground Robotic Gait Training with Functional Outcomes and Neuroplasticity After Spinal Cord Injury (DOOR SCI)
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La sperimentazione clinica NCT05218447 (DOOR SCI) è uno studio interventistico per Lesioni del midollo spinale, attualmente in arruolamento. Avviato il 20 maggio 2022, prevede di arruolare 144 partecipanti. Sotto la guida di Baylor Research Institute, dovrebbe concludersi entro il 14 settembre 2025. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 6 febbraio 2025.
Sommario breve
The DOOR SCI project examines dosing effects of robotic gait training (RGT) and transcranial magnetic stimulation (TMS) initiated during inpatient rehabilitation and continued through early outpatient rehabilitation
Descrizione dettagliata
Emerging evidence indicates that robotic exoskeleton use results in positive outcomes for those with chronic SCI, yet limited evidence exists for the acute setting. The potential benefit of RGT initiated during inpatient rehabilitation when recovery is greatest is unknown yet appears promising due to established principles of neuroplasticity and the fact that RGT incorporates the critical components of gait training. As a result of the lack of evidence, no clinical practice guidelines exist that delineate which gait retraining approach or dose during early phases of recovery results in the best outcomes for people with motor incomplete SCI. The DOOR SCI project examines dosing effects on 5 occasions over 9 months: (1) inpatient rehabilitation admission and (2) discharge, (3) after completing 24 RGT sessions, (4) 1-month post RGT, and (5) 9-months post SCI). To test the overarching goal, investigators propose three specific aims:
Aim 1: Using a randomized controlled trial, prospectively examine whether the dosing frequency [24 sessions delivered as high, moderate, or low frequency, defined by number days/week (4, 3, or 2 days/week over 6, 8, 12 weeks)] of RGT therapy provided during the acute/subacute recovery phase after motor incomplete SCI impacts outcomes compared to usual care only.
Aim 2: Investigate the difference over 9 months of the neuroplastic effect of RGT dosing as measured by single pulse TMS.
Aim 3: Evaluate the safety, tolerability, and feasibility of delivering different dosing frequencies of RGT from inpatient to outpatient rehabilitation settings.
Titolo ufficiale
Dosing of Overground Robotic Gait Training with Functional Outcomes and Neuroplasticity After Spinal Cord Injury
Condizioni
Lesioni del midollo spinalePubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:- Swank C, Trammell M, Bennett M, Ochoa C, Callender L, Sikka S, Driver S. The utilization of an overground robotic exoskeleton for gait training during inpatient rehabilitation-single-center retrospective findings. Int J Rehabil Res. 2020 Sep;43(3):206-213. doi: 10.1097/MRR.0000000000000409.
- Swank C, Sikka S, Driver S, Bennett M, Callender L. Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. Disabil Rehabil Assist Technol. 2020 May;15(4):409-417. doi: 10.1080/17483107.2019.1587014. Epub 2019 Mar 19.
- DiPasquale J, Trammell M, Clark K, Fowler H, Callender L, Bennett M, Swank C. Intensity of usual care physical therapy during inpatient rehabilitation for people with neurologic diagnoses. PM R. 2022 Jan;14(1):46-57. doi: 10.1002/pmrj.12577. Epub 2021 Apr 15.
- Swank C, Galvan C, DiPasquale J, Callender L, Sikka S, & Driver D. Lessons Learned with Robotic Exoskeleton Use During Rehabilitation - therapeutic and medical severity considerations. Technology & Disability. 2020; 32(2): 103-110.
- Suhalka A, da Silva Areas FZ, Meza F, Ochoa C, Driver S, Sikka S, Hamilton R, Goh HT, Callender L, Bennett M, Shih HT, Swank C. Dosing overground robotic gait training after spinal cord injury: a randomized clinical trial protocol. Trials. 2024 Oct 18;25(1):690. doi: 10.1186/s13063-024-08503-0.
Altri ID dello studio
- DOOR SCI
- BSWRI IRB 021-205
Numero NCT
Data di inizio (effettiva)
2022-05-20
Ultimo aggiornamento pubblicato
2025-02-06
Data di completamento (stimata)
2025-09-14
Arruolamento (previsto)
144
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Exoskeleton
Wearable assistive technology
Transcranial magnetic stimulation
Robotic gait training
Wearable assistive technology
Transcranial magnetic stimulation
Robotic gait training
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Triplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleLow Frequency Subjects will receive 2 sessions of robotic gait training (RGT) per week for 12 weeks | Robotic Gait Training Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.
Subjects will wear an exoskeleton device and receive robotic gait training (RGT) with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will complete 24 robotic gait training sessions over different durations during outpatient rehabilitation. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity. |
SperimentaleModerate Frequency Subjects will receive 3 sessions of robotic gait training (RGT) per week for 8 weeks | Robotic Gait Training Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.
Subjects will wear an exoskeleton device and receive robotic gait training (RGT) with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will complete 24 robotic gait training sessions over different durations during outpatient rehabilitation. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity. |
SperimentaleHigh Frequency Subjects will receive 4 sessions of robotic gait training (RGT) per week for 6 weeks | Robotic Gait Training Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.
Subjects will wear an exoskeleton device and receive robotic gait training (RGT) with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will complete 24 robotic gait training sessions over different durations during outpatient rehabilitation. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity. |
Comparatore attivoControl Group Subjects will receive usual care gait training without robotic gait training | Usual Care (UC) Gait Training Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.
Subjects will complete gait training with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in Walking Index for Spinal Cord Injury - II (WISCI-II) from baseline | The WISCI-II defines the physical limitation for gait secondary to impairment at the person level and indicates the ability of a person to walk after SCI. The WISC-II rank orders the ability a person to walk on a scale of 0-20 with 0 representing no ability to stand or participate in assisted walking and 20 representing an ability to walk 10 meters with no devices, no braces, and no physical assistance. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in 10-Meter Walk Test (10MWT) | The 10MWT assesses gait speed (m/s) over a short duration. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Spinal Cord Independence Measure (SCIM) | The SCIM assesses the ability of a person with spinal cord injury (SCI) to preform specified tasks independently, with assistance, or with assistive devices.
SCIM is composed of 19 items with total SCIM scores ranging from 0 (required assistance) to 100 (independence). A higher score means greater independence. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Numerical Pain Rating Scale (NPRS) | Pain is a significant problem in many individuals with SCI. A 0-10 Point Numerical Pain Rating Scale (NRS) is recommended as the outcome measure for pain intensity after SCI during acute and subacute phases. Pain severity can be categorized into 3 distinct groups as relates to pain interference: 1-3 (mild), 4-7 (moderate), 8-10 (severe). A higher score means greater pain severity. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Fatigue Severity Scale (FSS) | The Fatigue Severity Scale (FSS) is used to measure fatigue in neurologic disorders and measures the effects of fatigue on function. It is measure on the following scale:
1. \- Strongly Disagree
2. \- Disagree
3. \- Slightly Disagree
4. \- Neutral
5. \- Slightly Agree
6. \- Agree
7. \- Strongly Agree A higher score means greater fatigue. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Penn Spasm Frequency Scale (PSFS) | The PSFS is a self-report measure to assess a patient's perception of spasticity frequency and severity following a SCI. With excellent internal consistency (ICC = 0.90), the current version was modified from the original to include both frequency and severity. A higher score means greater magnitude in spasms. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Patient Health Questionnaire - 9 (PHQ-9) | The PHQ-9 is a self-report measure to assess the presence of depressive symptoms. Each items is scored on the following scale:
0 - not at all
1. \- several days
2. \- more than half the days
3. \- nearly daily
Total scores are calculated by adding all the score and provides a possible depression severity score:
none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27). A higher score means greater severity in depressive symptoms. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Life Satisfaction Questionnaire (LISAT) | The LISAT is a nine-item quality of life questionnaire suitable for SCI populations containing a single item assessing overall life satisfaction, along with eight additional domain-specific items. Items are answered on a 6-point likert scale that ranges from 1 (very dissatisfied), to 6 (very satisfied). The total Life Satisfaction score is computed as the mean of the item scores and the results are divided into dissatisfied (1-4) and satisfied (5-6). A higher score score means greater life satisfaction. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Physical Activity by GT9x Actigraph accelerometer | Active energy expenditure will be measured in counts per day using a GT9x Actigraph accelerometer. Patient will be instructed to wear the watch on an unaffected wrist for one week. Higher counts represent greater physical activity. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Change in Neurophysiologic biomarkers by single pulse transcranial magnetic stimulation (TMS) | Motor evoked potential (MEP) amplitudes will be measured and indexed from lower extremity muscle by single pulse transcranial magnetic stimulation (TMS). | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset |
Criteri di eleggibilità
Età idonea
Bambino, Adulto, Adulto anziano
Età minima
16 Years
Sessi idonei
Tutti
- All types of motor incomplete SCI (traumatic and non-traumatic)
- Acute/Subacute phase of recovery
- Medically stable as deemed by physician
- Undergoing medical care and rehabilitation at Baylor Scott & White Institute for Rehabilitation
- Both genders and all races and ethnicities
- Meet the Ekso robotic exoskeleton frame limitations
- Continence of or a program for bladder and bowel management
- Concurrent moderate to severe traumatic brain injury (TBI)
- Degenerative diagnoses
- Pre-morbid developmental disability, significant psychological diagnosis, or other cognitive impairment
- Pregnancy
Baylor Research Institute- United States Department of Defense
- Texas Woman's University
Parte responsabile dello studio
Chad Swank, Investigatore principale, Research Investigator, Baylor Research Institute
Contatti principali dello studio
Contatto: Faith Meza, MPH, 469-531-1577, [email protected]
Contatto: Christa Ochoa, MPH, [email protected]
1 Centri dello studio in 1 paesi
Texas
Baylor Scott & White Institute for Rehabilitation, Dallas, Texas, 75246, United States
Baylor Scott & White Institute for Rehabilitation, Contatto
In arruolamento