An Engineering-Based Balance Assessment and Training Platform (BATP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03994770|
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Balance Deficits Stroke||Diagnostic Test: Balanced Reach Assessment and Training Protocol||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Once the BATP is developed 20 stroke subjects will be recruited and the BATP's Assessment Module will be administered in order to verify its operation. After this is complete 10 stroke subjects will be randomly selected from this group and will undergo three one-hour training sessions over the course of one week to assess the operation of the BATP's Training Module.|
|Masking:||None (Open Label)|
|Official Title:||An Engineering-Based Balance Assessment and Training Platform|
|Estimated Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Older people who have suffered a stroke
Diagnostic Test: Balanced Reach Assessment and Training Protocol
Three one-hour training sessions for one week in the Balanced Reach Training Protocol
- Root Mean Squared Deviation between Center of Mass and Center of Base of Support (RMSD) [ Time Frame: Assess change between base line (just prior to training) and last 90 seconds of last training session at end of 1 week ]Measure of Balance Capability. Root Mean Squared Deviation (RMSD) records the root mean squared distance between the ground plane projection of whole-body Center of Mass and the center of the Base of Support during performance of the balanced reach task, in centimeters. It ranges from zero to the distance from the center of the Base of Support to the boundary of the Base of Support. Larger deviations indicate better performance than smaller deviations.
- Multi-Directional Reach Test [ Time Frame: Assess change between base line (just prior to training) and within 24 hours of the end of training (1 week) ]Measures ability to lean and reach. Multi-Directional Reach Test records the distance in centimeters that one can reach in the forward, backward, rightward, and leftward directions; by bending at the waist and reaching with arm extended in each associated direction. Larger distances indicate better performance than smaller distances.
- Falls Efficacy Scale [ Time Frame: Assess change between base line (just prior to training) and within 24 hours of the end of training (1 week) ]Assesses fear of falling. The Falls Efficacy Scale is a self-report questionnaire providing information on level of concern about falls for a range of activities of daily living. The questionnaire contains 16 items scored on a four-point scale (1 = not at all concerned to 4 = very concerned). The overall score is the sum of the 16 scores that are provided and ranges from 1to 64. Overall scores between 16-19 indicate low fear of falling; 20-27 indicates moderate fear of falling; and 28-64 indicates high fear of falling. Lower scores are better than higher scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994770
|Contact: Joseph E Barton, MD PhD||(202) email@example.com|
|United States, Maryland|
|Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD||Not yet recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Joseph E Barton, MD PhD 202-337-5921 firstname.lastname@example.org|
|Principal Investigator: Joseph E. Barton, MD PhD|
|Principal Investigator:||Joseph E. Barton, MD PhD||Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|