High Vs Low Intensity Virtual Reality Gait Training in Individuals with Chronic Stroke

Indiana University

Status: Withdrawn

Conditions: Stroke; Gait Disorders, Neurologic

Treatments: Other: Virtual reality gait training

Study type: Interventional

Funder types: Other

Identifiers

NCT06522477

23656

Details and patient eligibility

About

The purpose of this pilot study is to investigate the feasibility of 1) providing virtual reality walking training using a custom developed setup able to be replicated in routine clinical practice and 2) combining the virtual reality training with high-intensity gait training.

Full description

This study will utilize a randomized-crossover design. Following confirmation of eligibility and completion of Baseline 1 testing, individuals will be randomized to receive up to 15 visits over approximately 5 weeks of either high or low intensity virtual reality gait training. Following which, individuals will undergo Post 1 testing to capture potential change in outcomes following the intervention. Participants will then take at least a 4-week break before returning to complete Baseline 2 testing and up 15 visits over 5 weeks of the alternative intervention before finally completing Post 2 testing.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral deficits following stroke > 6 months prior; however individuals > 4 months post-stroke are eligible for consenting, but final eligibility and potential enrollment will not occur until > 6 months
• Age 18-85 years
• Weight < 350 pounds
• Able to follow a 3-step command
• Able to ambulate with self-selected gait speeds between 0.01-1.0 m/s without physical assistance, but with below knee bracing and/or assistive device as needed
• Lower extremity Fugl-Meyer < 34
• Medical clearance to participate

Exclusion criteria

• Evidence of cerebellar ataxia
• Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities
• Currently participating in other physical therapy
• > 50 units of Botox in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis (AFO) within the past three months. Note that participants may be consented prior to 3 months post-injection; however, eligibility will be determined post 3 months.
• Unable to read > 50% of the letters on the 20/70 line of the Snellen Chart with customary eye wear at a distance of 20 feet

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 2 patient groups

High-intensity followed by low-intensity virtual reality gait training

Experimental group

Description:

Individuals randomized to this group will first perform high-intensity virtual reality gait training and following a 4-week washout period will complete low-intensity virtual reality gait training.

Treatment:

Other: Virtual reality gait training

Low-intensity followed by high-intensity virtual reality gait training

Experimental group

Description:

Individuals randomized to this group will first perform low-intensity virtual reality gait training and following a 4-week washout period will complete high-intensity virtual reality gait training.

Treatment:

Other: Virtual reality gait training