Locomotor Recovery Following Traumatic Brain Injury

NCT04503473 | Completed DMC

• 1 other identifier: 1911962819
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effectiveness of two different walking training interventions on the recovery of strength, mobility, walking and other measures of health in individuals following traumatic brain injury. During this study, participants will aim to complete up to 15 training sessions over 4-5 weeks of each intervention with at least a 4 week break between interventions. Each training session will last approximately 1 hour, while testing sessions performed at the beginning and end of each intervention will last approximately 3-4 hours. Participation in this research study may last up to 6 months including screening and baseline testing. The possible benefits to participant from participation in this study include increased strength of the participants leg muscles and improved walking ability

Conditions

Traumatic Brain Injury (TBI)

Keywords

Traumatic Brain Injury; TBI; Walking

Outcome Measures

Primary Outcomes (2)

• Change in Gait speed

  Gait speed is valid, reliable, and sensitive measures related to overall functional ability, and will be assessed by blinded rates. This measure will be performed by blinded assessors who do not participate in the training. Gait speed will be measured at self-selected speeds (SSS; instructions to "walk at normal comfortable pace") and fastest-possible speed (FS: "as fast as you safely can") using the Zeno Walkway (Protokinetics, Haverton, PA).

  Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks

• Change in Endurance

  Endurance is valid, reliable, and sensitive measures related to overall functional ability, and will be assessed by blinded rates. This measure will be performed by blinded assessors who do not participate in the training. Gait endurance will be tested using the 6MWT (m) with instructions similar to SSS to minimize fall risk.

  Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks

Secondary Outcomes (3)

• Change in Strength

  Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 6 weeks

• Change in gait quality

  Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks

• Change in metabolic capacity

  Baseline 1, Post 6 weeks, Baseline 2, Post 6 weeks

Study Arms (2)

High Intensity Stepping Training

EXPERIMENTAL

The primary goal will be to perform continuous stepping while maintaining HR within 70-85% maximum predicted HR (if patients are deconditioned, PTs will gradually increase intensity to desired levels as tolerated). We will also record Ratings of Perceived Exertion (RPE) every 3-5 minutes, with goals of 15-18. Sessions will be divided into \~10 minute increments (\~25% of sessions) between speed-dependent treadmill training (described above for treadmill stepping), skill-dependent treadmill training, overground training, and stair climbing.

Behavioral: High Intensity Stepping Training

Conventional Therapy

ACTIVE COMPARATOR

Participants provided conventional therapy will perform various standardized exercise tasks during 40 minutes of 1 hr sessions. The type of therapeutic activities is based on published normative data of typical activities performed during clinical physical therapy sessions with focus on strengthening activities (25% of session); balance activities (25%); locomotor activities (25%), and combined stretching exercises (10-15%) and transfers (10-15%). Intensity of activities will be targeted at 30-40% of their HR reserve in attempts to maintain consistent intensities between training groups.

Behavioral: Conventional Therapy

Interventions

High Intensity Stepping Training BEHAVIORAL

The goals will be to maximize stepping activity at high intensities for 40 minutes per 1 hour session, with rest breaks as needed Conventional Therapy: : Participants provided conventional therapy will perform various standardized exercise tasks during 40 minutes of 1 hr sessions

Also known as: HIT

High Intensity Stepping Training

Conventional Therapy BEHAVIORAL

Participants provided conventional therapy will perform various standardized exercise tasks during 40 minutes of 1 hr sessions

Conventional Therapy

Eligibility Criteria

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

You may qualify if:

• \> 6 months post traumatic brain injury
• years old
• ability to walk without physical assistance
• Self selected walking speed of 0.01-1.0 m/s

You may not qualify if:

• \<18 years old
• \>75 years old
• self selected walking speed of \> 1.0 m/s
• \< 3 months from botulinum toxin injection
• Above the knee brace
• Currently receiving physical therapy

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

Location

Related Publications (1)

• Plawecki A, Henderson CE, Lotter JK, Shoger LH, Inks E, Scofield M, Voigtmann CJ, Katta-Charles S, Hornby TG. Comparative Efficacy of High-Intensity Training Versus Conventional Training in Individuals With Chronic Traumatic Brain Injury: A Pilot Randomized Controlled Study. J Neurotrauma. 2024 Apr;41(7-8):807-817. doi: 10.1089/neu.2023.0494. Epub 2024 Jan 25.

  PMID: 38204184 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• George Hornby, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

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: Professor of Physical Medicine & Rehabilitation

Model Details: Baseline characteristics and training parameters (steps, intensity parameters) will be compared between treatment groups using independent group comparisons. (ANOVA, Kruskal-Wallis, or Chi-squared tests as appropriate).

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: August 7, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

US (1)