Variable Intensive Early Walking Post-Stroke - 2 (VIEWS-2)

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT05727930
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • High-intensity, task-specific (i.e., walking) interventions — BEHAVIORAL
    Up to 30 1-hr sessions of training focused on walking trying to achieve higher cardiovascular intensities
  • High-intensity, non-specific physical therapy interventions — BEHAVIORAL
    Up to 30 1-hr sessions of training focused on varied physical interventions trying to achieve higher cardiovascular intensities
  • Low-intensity, task-specific physical therapy interventions — BEHAVIORAL
    Up to 30 1-hr sessions of training focused on walking trying to achieve lower cardiovascular intensities
  • Low-intensity, non-specific physical therapy interventions — BEHAVIORAL
    Up to 30 1-hr sessions of training focused on varied physical interventions trying to achieve lower cardiovascular intensities

Study Details

The proposed research will evaluate the individual and combined effects of task-specificity and intensity of rehabilitation interventions on locomotor function, community mobility and quality of life in patients with subacute (1-6 months) post-stroke.

Key Dates

Start date
Jan 11, 2023
Status verified
Mar 2026
Primary completion
Oct 15, 2028
Completion
Oct 15, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: High-intensity, task-specific (i.e., walking) interventions
    30 1-hour (hr) sessions of walking training targeting higher cardiovascular intensities over approximately 2 months
  • Active Comparator: High-intensity, non-specific physical therapy interventions
    30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting higher cardiovascular intensities over approximately 2 months
  • Active Comparator: Low-intensity, task-specific physical therapy interventions
    30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting lower cardiovascular intensities over approximately 2 months
  • Active Comparator: Low-intensity, non-specific physical therapy interventions
    30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting lower cardiovascular intensities over approximately 2 months

Primary Outcome Measure

Changes in 6 minute walk test [ Time Frame: Approximately 8-10 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rehabilitation Hospital of IndianaIndianapolisIndiana46254
George Hornby
317-329-2353

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