Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02267668
Other study ID # 11-13-04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2014
Est. completion date March 8, 2018

Study information

Verified date May 2018
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 8, 2018
Est. primary completion date March 8, 2017
Accepts healthy volunteers No
Gender All
Age group 14 Years to 22 Years
Eligibility Inclusion Criteria:

1. 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;

2. Participants are high school and college age (14-22 years old);

3. English speaking. -

Exclusion Criteria:

1. Outside of age range for the study (High school or college age)

2. Have physical injuries or comorbidities that restrict the athlete from engaging in the exercise intervention

3. Not fluent in English -

Study Design


Intervention

Behavioral:
STEP
Physical therapists guide participants through novel set of assigned exercises
Control
Participants self-guide through standard exercises

Locations

Country Name City State
United States University Hospitals Case Medical Center Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Centers for Disease Control and Prevention. Nonfatal traumatic brain injuries related to sports and recreation activities among persons aged =19 years--United States, 2001-2009. MMWR Morb Mortal Wkly Rep. 2011 Oct 7;60(39):1337-42. — View Citation

Gagnon I, Galli C, Friedman D, Grilli L, Iverson GL. Active rehabilitation for children who are slow to recover following sport-related concussion. Brain Inj. 2009 Nov;23(12):956-64. doi: 10.3109/02699050903373477. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Concussion symptom resolution Symptom self-reports; improvement reflected by points on the scale 6 weeks
Primary Neuropsychological testing Improved cognitive performance with the treatment, reflected in standard scores on cognitive measures. 6 weeks
Primary Postural stability Improved balance with the treatment, reflected in reductions in errors on the Balance Error Scoring System (BESS). 6 weeks
See also
  Status Clinical Trial Phase
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05503316 - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System N/A
Completed NCT04356963 - Adjunct VR Pain Management in Acute Brain Injury N/A
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Terminated NCT03698747 - Myelin Imaging in Concussed High School Football Players
Recruiting NCT05130658 - Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training N/A
Recruiting NCT04560946 - Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI N/A
Completed NCT05160194 - Gaining Real-Life Skills Over the Web N/A
Recruiting NCT02059941 - Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines N/A
Recruiting NCT03940443 - Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
Recruiting NCT03937947 - Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
Completed NCT04465019 - Exoskeleton Rehabilitation on TBI
Recruiting NCT04530955 - Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS) N/A
Recruiting NCT03899532 - Remote Ischemic Conditioning in Traumatic Brain Injury N/A
Suspended NCT04244058 - Changes in Glutamatergic Neurotransmission of Severe TBI Patients Early Phase 1
Completed NCT03307070 - Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury N/A
Recruiting NCT04274777 - The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
Withdrawn NCT04199130 - Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI N/A
Withdrawn NCT05062148 - Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery N/A
Withdrawn NCT03626727 - Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia Early Phase 1