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Completed

NCT Number: NCT02267668

Subsymptom Threshold Exercise Protocol Following Mild TBI

The study will monitor outcomes of two interventions to develop a best practice in the treatment of mild Traumatic Brain Injury (mTBI).

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Key information

Conditions

Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

14 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

About this study

The proposed pilot randomized controlled clinical trial (RCCT) will provide preliminary data to examine the effect of a novel intervention to promote brain health after mild Traumatic Brain Injury (mTBI). The study will implement a randomized controlled clinical trial of a 6 week exercise intervention (STEP) for participants with persistent mTBI symptoms, comparing STEP to standard of care practice in the controls. We will demonstrate the feasibility and acceptability of the STEP intervention. We hypothesize that STEP will lead to meaningful improvement on objective measures of self-reported mTBI symptoms, formal neuropsychological performance, and postural stability.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who have sustained a concussion and have not experienced symptom resolution by 4 weeks, as indicated by a Post-Concussive Scale - Revised (PCS-R) score of 20 or higher at 4 weeks post-injury or beyond;
  • Participants are high school and college age (14-22 years old);
  • English speaking. -

Exclusion criteria

  • Outside of age range for the study (High school or college age)
  • Have physical injuries or comorbidities that restrict the athlete from engaging in the exercise intervention
  • Not fluent in English -

Treatment and study plan

STEP

Behavioral

Physical therapists guide participants through novel set of assigned exercises

Other names: Subsymptom Threshold Exercise Protocol

Control

Behavioral

Participants self-guide through standard exercises

Primary outcomes

  1. Concussion symptom resolution

    Time frame: 6 weeks

    Symptom self-reports; improvement reflected by points on the scale

  2. Neuropsychological testing

    Time frame: 6 weeks

    Improved cognitive performance with the treatment, reflected in standard scores on cognitive measures.

  3. Postural stability

    Time frame: 6 weeks

    Improved balance with the treatment, reflected in reductions in errors on the Balance Error Scoring System (BESS).

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Subsymptom Threshold Exercise Protocol (STEP) to Recovery Following Mild Traumatic Brain Injury: A Pilot Randomized Controlled Clinical Trial

Acronym: STEP

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Oct 17, 2014
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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