NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations)

NCT06269367 | Completed Results

• 2 other identifiers: HUM002261491R41HD111289-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

An affordable and easy to use gait-assistive device for stroke survivors to use at home is yet to be developed. This study is intended to modify the current design of the NewGait device to specifically work for stroke survivors based on feedback from patients and clinicians. Consequently, conducting a short-term biomechanical gait study is planned to determine the usability and functionality of the NewGait device compared to other comparative devices.

Conditions

Stroke

Keywords

gait training; balance; Stroke survivors

Outcome Measures

Primary Outcomes (2)

• Gait Speed

  Changes in gait speed (from baseline) as measured using the 10 Meter Walk Test between the experimental (NewGait) and control conditions. Participants were timed during the 10 Meter Walk Test to determine their self-selected gait speed while walking overground in a hallway. In this test, participants walked down a 14 meter walkway, and a stopwatch was used to time how long it took participants to cross the intermediate 10 meter distance. The baseline measure for the first device was taken immediately prior to the intervention. Participants then wore the first device, and the during-training measure was taken immediately. After this, participants received training with the device for about 15 minutes, following which, the device was removed and the post-intervention measure was taken immediately for the first device. Participants then rested for 20-30 minutes. This entire process was repeated with the second device. All measures were obtained on the same day.

  Up to 2 hours

• Ankle Muscle Activation

  Changes in ankle muscle activation of the leg muscles as measured using surface electromyography between the experimental (NewGait) and control conditions. Muscle activation ranges from 0 to no upper limit, and higher activation meant that the muscle was being used more. The baseline measure for the first device was taken immediately prior to the intervention. Participants then wore the first device, and the during-training measure was taken immediately. After this, participants received training with the device for about 15 minutes, following which, the device was removed, and the post-intervention measure was taken immediately for the first device. Participants then rested for 20-30 minutes. This entire process was repeated with the second device. All measures were obtained on the same day.

  Up to 2 hours

Secondary Outcomes (1)

• Changes in Paretic Leg Propulsive Force

  Up to 2 hours

Other Outcomes (3)

• Changes in Paretic Leg Loading (i.e., Vertical Ground Reaction Force)

  Up to 2 hours

• Changes in Other Lower Extremity Muscle Activation

  Up to 2 hours

• Muscle Coordination

  Up to 2 hours

Study Arms (2)

NewGait

EXPERIMENTAL

Participants will put on the NewGait device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training.

Other: NewGait

Control

OTHER

Participants will put on the Control device and walk on the treadmill and over ground. Participants may receive biofeedback of their gait patterns to engage them in the training.

Other: Control wearable limb orthotic device

Interventions

NewGait OTHER

wearable limb orthotic device

NewGait

Control wearable limb orthotic device OTHER

wearable limb orthotic device

Control

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral cortical or subcortical stroke
• Chronic stroke (≥ 6 months) At least 6 months following their first unilateral stroke
• Able to walk independently with/without assistive devices for 5-10 mins (\~150m)
• No significant cognitive deficits as determined by the Mini Mental State Examination (MMSE) score (score≥ 22)

You may not qualify if:

• Cerebellar stroke
• Traumatic or vascular brain injury
• History of unstable heart condition, uncontrolled diabetes/hypertension
• History of a recent lower-extremity trauma or fracture
• History of a recent significant orthopedic or neurological conditions that could limit walking ability (e.g., multiple sclerosis, total knee replacement)
• Documented history of significant spatial neglect
• ankle joint contractures or significant spasticity in the lower limbs
• History of a recent Botulinum Toxin (Botox) injection to the lower-extremity muscles (≤ 3 months)
• Pregnant or actively planning to become pregnant (self-reported)- Inability to communicate or unable to consent

Sponsors & Collaborators

• University of Michigan: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Physical Medicine & Rehabilitation 325 E Eisenhower Pkwy Suite 3011

Ann Arbor, Michigan, 48108, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Chandramouli Krishnan
• Organization: University of Michigan

mouli@umich.edu

(734) 936-4031

Study Officials

• Chandramouli Krishnan, PT, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Medicine and Rehabilitation

Model Details: Participants will be randomly assigned to the two device interventions but will receive both interventions.

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: April 1, 2024
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)