Upper Extremity Rehabilitation With the BURT Robotic Arm
|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: NCT03965403|
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke Hemiparesis||Device: Arm motor function retraining with BURT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants will receive the same intervention|
|Masking:||None (Open Label)|
|Official Title:||Upper Extremity Rehabilitation With the BURT Robotic Arm: a Feasibility Study|
|Actual Study Start Date :||October 23, 2018|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Arm motor function retraining with BURT
All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.
Device: Arm motor function retraining with BURT
Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions
- Fugl-Meyer Upper Extremity Scale [ Time Frame: Change from baseline scores at 6 weeks ]Assessment of upper extremity impairments. Individual items of the scale are summed for a total score ranking from 0 to 66. Higher scores indicate better outcomes.
- Goal Attainment Scale [ Time Frame: Change from baseline scores at 6 weeks ]Standardized measure of goals selection and scaling to calculate the extend to which the participant's goals are met. Positive scores indicates goals are better than expected, score of 0 indicates goals are met and negative scores indicates goals aren't met.
- Wolf Motor Function Test [ Time Frame: Change from baseline scores at 6 weeks ]Assessment of upper extremity function
- Motor Activity Log [ Time Frame: Change from baseline scores at 6 weeks ]Use of upper extremity in daily life
- Modified Ashworth Scale [ Time Frame: Change from baseline scores at 6 weeks ]Assessment of muscle tone for upper extremity muscles. Score rank from 0 (no tone) to 4 (no movement possible). Lower scores indicates a better outcome.
- Articulations range of motion [ Time Frame: Change from baseline scores at 6 weeks ]Assessment of arm range of motion with goniometry. Results are reported in degrees and higher ranges include better outcomes.
- Manual muscle testing scale [ Time Frame: Change from baseline scores at 6 weeks ]Assessment of arm muscle strength using the manual muscle testing scale ranking from 0 (no contraction) to 5 (maximal strength). Higher scores indicate better outcomes.
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): NCT03965403
|Contact: Paolo Bonato, PhDemail@example.com|
|Contact: Catherine Adans-Desterfirstname.lastname@example.org|
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital||Recruiting|
|Boston, Massachusetts, United States, 02129|
|Contact: Catherine P Adans-Dester, PT 617-952-6321 email@example.com|
|Principal Investigator: Paolo Bonato, PhD|