Upper Extremity Rehabilitation With the BURT Robotic Arm
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|ClinicalTrials.gov Identifier: NCT03965403|
Recruitment Status : Completed
First Posted : May 29, 2019
Results First Posted : February 19, 2020
Last Update Posted : February 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke Hemiparesis||Device: Arm motor function retraining with BURT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 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|
|Actual Primary Completion Date :||May 16, 2019|
|Actual Study Completion Date :||May 16, 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
- Changes From Baseline in Fugl-Meyer Upper Extremity Scores [ Time Frame: 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.
- Changes From Baseline in Goal Attainment Scale Scores [ Time Frame: 6 weeks ]
Standardized measure of goals selection and scaling to calculate the extend to which the participant's goals are met.
The Goal Attainment Scale ranges from -2 to +2. Positive scores indicates goals are better than expected, score of 0 indicates goals are met and negative scores indicates goals aren't met.
- Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale) [ Time Frame: 6 weeks ]Assessment of upper-extremity function by the performance time of the Wolf Motor Function Test). The average of the 15 items is reported. The time ranges from 0 to 120 seconds. A decrease in performance time is associated with improved upper-extremity function.
- Changes From Baseline in Motor Activity Log Scores [ Time Frame: 6 weeks ]Use of upper extremity in daily life. The self-reported amount of use is reported on a scale from 0 to 5. A score of zero is assigned when the hemiparetic side is not used during the activity of daily living, a score of 5 is assigned when the hemiparetic side is used as much as before the stroke. The 30 items of the scale are averaged. Higher scores are a sign of better use in daily life.
- Changes From Baseline in Modified Ashworth Scale Scores [ Time Frame: 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.
Tone at the shoulder and elbow were measured
- Changes From Baseline in Articulations Range of Motion [ Time Frame: 6 weeks ]Assessment of active arm range of motion with goniometry. Results are reported in degrees and higher ranges include better outcomes.
- Changes From Baseline in Manual Muscle Testing Scale Scores [ Time Frame: 6 weeks ]Assessment of arm muscle strength using the manual muscle testing scale ranking from 0 (no contraction) to 10 (maximal strength). Higher scores indicate better outcomes.
- Changes From Baseline in Wolf Motor Function Test Scores (FAS Subcale) [ Time Frame: 6 weeks ]
Assessment of upper-extremity function with the Functional ability subscale of the Wolf Motor Function Test.
The average of the 15 items is reported. Scores ranges from 0 to 5, they rate the quality of the movement performance. 0= do not attempt, up to 5= identical to contralateral side. Higher scores are associated with better movement quality.
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
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital|
|Boston, Massachusetts, United States, 02129|