Effect of High-Intensity Gait Training Using a Treadmill on Locomotion Recovery in Traumatic Brain Injury Patients

NCT05622786 | Terminated

• 1 other identifier: IRB-21-1512
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The project will consist of subjects who have suffered Traumatic Brain Injury (TBI) and who are able to ambulate on treadmill with or without a harness system. This will be a 4-week controlled study consisting of two groups of TBI patients, high-intensity intervention group and low-intensity control group. Both groups will receive physical therapy treatment 3 times per week for 1 hour. The intervention group will undergo 30-minute sessions of high-intensity walking on a treadmill with an overhead harness attached for safety. In addition, they will also get up to 30-minutes of low-intensity physical therapy in order to receive 1 hour of treatment time. The control group will undergo only low-intensity physical therapy activities for 1-hour. Low-intensity physical therapy will include strength exercises, stretches, balance, and low-intensity gait training. All participants in both groups will complete these outcome measures on the first day of the study, after 2 weeks of participation, and again at the end of 4 weeks or on their last day before discharge from Carilion's services. Later on, all participants in both groups will be followed up to complete the same set of outcome measures at the end of 1 month since completion of the protocol. This follow up session will take up to 45 minutes to complete.

Conditions

Traumatic Brain Injury; Gait Disorders, Neurologic

Keywords

High-intensity; Gait training; Traumatic Brain injury; Heart rate; Treadmill

Outcome Measures

Primary Outcomes (7)

• Five Times Sit to Stand Test

  Stand up and sit down as quickly as possible 5 times, keeping your arms folded across your chest.

  Through intervention and follow-up period, up to 8 weeks. This would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up.

• Six Minute Walk Test (6MWT)

  a sub-maximal exercise test used to assess walking endurance and aerobic capacity. Participants will walk around the perimeter of a set circuit for a total of six minutes.

  Through intervention and follow-up period, up to 8 weeks. This would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up.

• 10 Meter Walk Test (10mWT)

  Assesses walking speed in meters/second (m/s) over a short distance.

  Through intervention and follow-up period, up to 8 weeks. This would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up.

• Berg Balance Scale (BBS)

  Used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. The minimum value of this assessment is 0, and the maximum is 56. A higher score means a better outcome.

  Through intervention and follow-up period, up to 8 weeks. This would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up.

• Timed Up and Go (TUG)

  Assesses a person's mobility that requires both static and dynamic balance.

  Through intervention and follow-up period, up to 8 weeks. This would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up.

• Timed Up and Go (Cognitive)

  Complete a TUG test while counting backward by three from a randomly selected number between 20 and 100.

  Through intervention and follow-up period, up to 8 weeks. This would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up.

• Montreal Cognitive Assessment (MoCA)

  A rapid screening instrument for mild cognitive dysfunction. The minimum value of this assessment is 0, and the maximum is 30. A higher score means a better outcome.

  Through intervention and follow-up period, up to 8 weeks. This would be administered at the beginning, at the end of 2 weeks, at the end of 4 weeks of interventions, and finally at the end of 4 weeks following end of interventions for follow-up.

Study Arms (2)

High-Intensity Treadmill Gait Training (HIGT)

EXPERIMENTAL

High-intensity walking physical therapy with some low intensity therapy.

Other: HIGT - physical rehab

Low Intensity Physical Therapy

ACTIVE COMPARATOR

Low-intensity gait activities, exercises (such as lower extremity strength training with or without weights or electrical stimulation, sit to stands from a chair, mat exercises for upper/lower extremities and core strength, etc.), stretches, balance training activities, and other therapeutic activities (such as transfers, bed mobility training, etc.).

Other: Low intensity physical therapy

Interventions

HIGT - physical rehab OTHER

High Intensity Gait Training using treadmill and overhead harness for fall prevention

High-Intensity Treadmill Gait Training (HIGT)

Low intensity physical therapy OTHER

Low Intensity Gait Activities

Low Intensity Physical Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical and treadmill screening clearance to participate in this study
• Persons with mild, moderate, or severe Traumatic Brain Injury at onset (first time or repeats)
• years old persons who are able to ambulate on treadmill with or without assistive devices and with or without need for bodyweight-support harness system
• Ability to communicate with investigators to follow protocol instructions and respond appropriately
• Patients who have decision-making capacity and are able to consent for themselves

You may not qualify if:

• Unstable orthopedic conditions, for example, unstable craniectomies or weight-bearing restrictions.
• Unstable cardiac conditions including, unstable angina, unstable cardiac dysrhythmias, myocardial ischemia or hypertension at rest (systolic BP \> 140mm Hg and diastolic BP \>90 mm Hg, or if over this range, then a physician must clear patient for participation)
• Acute systemic infection accompanied by fever, body aches or swollen lymph glands.
• Hospitalization for acute cardiac, pulmonary or metabolic conditions in the past 3 months.
• Any other physical or mental restrictions preventing participation in the research protocol.
• Women who are pregnant are being excluded as this is considered a high risk study. They will be asked via verbal questioning via the following statements, "Are you currently pregnant?" or "Are you planning to become pregnant?".
• Non-English Speakers

Sponsors & Collaborators

• Carilion Clinic: lead
• Radford University: collaborator
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Institute for Orthopaedics and Neurosciences

Roanoke, Virginia, 24014, United States

Location

Related Publications (8)

• Hornby TG, Reisman DS, Ward IG, Scheets PL, Miller A, Haddad D, Fox EJ, Fritz NE, Hawkins K, Henderson CE, Hendron KL, Holleran CL, Lynskey JE, Walter A; and the Locomotor CPG Appraisal Team. Clinical Practice Guideline to Improve Locomotor Function Following Chronic Stroke, Incomplete Spinal Cord Injury, and Brain Injury. J Neurol Phys Ther. 2020 Jan;44(1):49-100. doi: 10.1097/NPT.0000000000000303.

  PMID: 31834165 RESULT

• Moore JL, Nordvik JE, Erichsen A, Rosseland I, Bo E, Hornby TG; FIRST-Oslo Team. Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes. Stroke. 2020 Feb;51(2):563-570. doi: 10.1161/STROKEAHA.119.027450. Epub 2019 Dec 30.

  PMID: 31884902 RESULT

• Holleran CL, Rodriguez KS, Echauz A, Leech KA, Hornby TG. Potential contributions of training intensity on locomotor performance in individuals with chronic stroke. J Neurol Phys Ther. 2015 Apr;39(2):95-102. doi: 10.1097/NPT.0000000000000077.

  PMID: 25784587 RESULT

• Ada L, Dean CM, Morris ME, Simpson JM, Katrak P. Randomized trial of treadmill walking with body weight support to establish walking in subacute stroke: the MOBILISE trial. Stroke. 2010 Jun;41(6):1237-42. doi: 10.1161/STROKEAHA.109.569483. Epub 2010 Apr 22.

  PMID: 20413741 RESULT

• Macko RF, Ivey FM, Forrester LW, Hanley D, Sorkin JD, Katzel LI, Silver KH, Goldberg AP. Treadmill exercise rehabilitation improves ambulatory function and cardiovascular fitness in patients with chronic stroke: a randomized, controlled trial. Stroke. 2005 Oct;36(10):2206-11. doi: 10.1161/01.STR.0000181076.91805.89. Epub 2005 Sep 8.

  PMID: 16151035 RESULT

• Holleran CL, Hennessey PW, Leddy AL, Mahtani GB, Brazg G, Schmit BD, Hornby TG. High-Intensity Variable Stepping Training in Patients With Motor Incomplete Spinal Cord Injury: A Case Series. J Neurol Phys Ther. 2018 Apr;42(2):94-101. doi: 10.1097/NPT.0000000000000217.

  PMID: 29547484 RESULT

• Ardestani MM, Henderson CE, Salehi SH, Mahtani GB, Schmit BD, Hornby TG. Kinematic and Neuromuscular Adaptations in Incomplete Spinal Cord Injury after High- versus Low-Intensity Locomotor Training. J Neurotrauma. 2019 Jun 15;36(12):2036-2044. doi: 10.1089/neu.2018.5900. Epub 2019 Feb 1.

  PMID: 30362878 RESULT

• Gadelha A, Voigtmann C. High Intensity Gait Training in Anoxic Brain Injury: A Case Study. Archives of Physical Medicine and Rehabilitation. DOE: https://doi.org/10.1016/j.apmr.2021.07.596

  RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Courtney Perkins, DPT

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 21, 2022
• Study Start: October 7, 2022
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

US (1)