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Not yet recruiting NCT07226518

Walking and tSCS in Non-ambulatory Stroke Survivors

No phase Interventional Chronic Stroke Survivors Chronic Stroke Patients Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robot-assisted gait training and transcutaneous spinal cord stimulation in chronic non-ambulatory stroke survivors: pilot RCT trial, Robot assisted gait training alone.
Who it may be relevant to
Registry conditions: Chronic Stroke Survivors, Chronic Stroke Patients, Stroke. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Robot-assisted Gait Training and Transcutaneous Spinal Cord Stimulation in Chronic Non-ambulatory Stroke Survivors: Pilot RCT Trial

Overview

Rehabilitation interventions commonly used for stroke survivors include task-specific training, balance and strength exercises, and the use of assistive devices to enhance mobility and independence. Advanced technologies, such as body-weight-supported treadmill systems and robotic devices, may be employed when appropriate. Current rehabilitation therapies for stroke survivors are moderately effective with a limited effect size, especially in stroke survivors with severe impairment. Novel therapies, such as transcutaneous spinal cord stimulation (tSCS), may further improve outcomes in the target population. This pilot study will allow us to examine the feasibility and gather pilot data on a combined intervention of assistive gait training and tSCS in non-ambulatory stroke survivors.

Interventions

  • Device Robot-assisted gait training and transcutaneous spinal cord stimulation in chronic non-ambulatory stroke survivors: pilot RCT trial
    Participants in the experimental group will receive 30 minutes of robot assisted gait training (RAGT) transcutaneous spinal cord stimulation 3 times per week, 8 weeks, totaling 24 sessions. The gait training will utilize a treadmill equipped with a partial-body-weight support system and a lab-developed RAGT device. The RAGT protocol will be the same as in the control group
  • Device Robot assisted gait training alone
    Participants in the control group will receive 30 minutes of assisted gait training (RAGT), 3 times per week, for 8 weeks, totaling 24 sessions. The gait training will utilize a treadmill equipped with a partial-body-weight support system and a lab-developed RAGT device

Primary outcome measures

  • Cardiac Output (Measured by Impedance Cardiography - BIOPAC MP160 System) [Time frame: Before and after 24 training sessions (8 weeks)]

Eligibility criteria

Inclusion criteria

  • Age 18-80 years at time of consent
  • All genders included.
  • Chronic ischemic or hemorrhagic stroke >=6 months, with limited within-home comfortable walking speed <= 0.49 m/s and unable to walk independently in community (FAC <= 3)
  • Able to communicate with investigators, follow 2-step command, and correctly answer consent comprehension questions in English.
  • Currently not participating in treadmill walking exercises or exercises involving weight-bearing activities.
  • Have physicians' approval for exercise and be in a stable medical condition

Exclusion criteria

  • Hospitalization for cardiac or pulmonary disease within the past 3 months
  • Have musculoskeletal disorders that prevent the participant from participating in the exercise
  • Blood pressure higher than 200/110 mm Hg
  • Significant ataxia or unilateral spatial neglect (score of 2 on NIH stroke scale item 7 or 11)
  • Reported pain that limits or interferes with activities of daily living and physical activity/exercise
  • Diagnosis of other neurological diseases (multiple sclerosis, Alzheimer's disease, Parkinson's disease)
  • Diagnosis of severe depression (HADS score 15-21)
  • Unable to speak or understand English, and travel to the research laboratory.
  • Contraindications to tSCS and TMS

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • Neuromuscular Research Laboratory — Kansas City

Identifiers

NCT: NCT07226518 · STUDY00162114

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗