NCT06612723

Brief Summary

The purpose of this pilot study is to investigate the potential role of training frequency on locomotor outcomes following high-intensity gait training and provision of a home walking program.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
5mo left

Started Sep 2024

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Sep 2024Oct 2026

Study Start

First participant enrolled

September 16, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

September 20, 2024

Last Update Submit

January 26, 2026

Conditions

Stroke

Keywords

strokegaitrehabilitationhigh-intensityfrequency

Outcome Measures

Primary Outcomes (1)

  • 6-minute walk test

    Individuals will be asked to "cover as much ground as possible" over 6 mins. Heart rate will additionally be measured during this assessment (distance in m)

    After 12 weeks

Secondary Outcomes (1)

  • Peak treadmill speed

    After 12 weeks

Other Outcomes (7)

  • Functional Gait Assessment

    After 12 weeks

  • 30 second Sit to Stand Test

    After 12 weeks

  • Activity-Specific Balance Confidence (ABC) Scale

    After 12 weeks

  • +4 more other outcomes

Study Arms (2)

High frequency

EXPERIMENTAL

Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 6 weeks

Other: high-intensity gait trainingBehavioral: Physical activity coaching

Low frequency

ACTIVE COMPARATOR

Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 12 weeks

Other: high-intensity gait trainingBehavioral: Physical activity coaching

Interventions

high-intensity gait trainingOTHER

Individuals will perform up to 40 minutes of walking practice during 60 minute sessions while targeting heart rates of at least 70% heart rate reserve.

High frequencyLow frequency
Physical activity coachingBEHAVIORAL

Individuals will receive feedback on the minutes of walking activity performed on non-training days and provided coaching strategies to increase this metric.

High frequencyLow frequency

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Weight \< 350 pounds
  • Able to follow 3-step commands
  • Able to ambulate with self-selected gait speeds between 0.10-1.0 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

You may not qualify if:

  • 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 such that, in the judgement of the PI, could compromise the safety of the participant, limit the ability to complete the study, or compromise the objectives of the study.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Thomas G Hornby, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Henderson, PhD

CONTACT

317-329-2353henderce@iu.edu

Thomas G Hornby, PhD

CONTACT

317-329-2353tghornby@iu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2024

First Posted

September 25, 2024

Study Start

September 16, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations

US(1)