Trial Outcomes & Findings for Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training (NCT NCT01050231)

NCT ID: NCT01050231

Last Updated: 2021-04-19

Results Overview

We measured the Box and Blocks Test scores at baseline evaluation, after each intervention, and at the 3-month follow up evaluation. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline, Post first intervention at 5 weeks, post second intervention at 11 weeks, and 3-month after the completion of the second intervention.
• Results posted on: 2021-04-19

Participant Flow

Participant milestones

Measure	Individual Joints and Functional Multi-joints Tasks Robotic group(Type I) Type II Robotic therapy (Individual joints only): Subjects participate in 11 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program. The robotic exoskeleton assists in arm and hand movements as the patient play interactive computer games.	Functional Multi-joints Activities and Individual Joints Robotic group (Type II) Type I Robotic Group (Functional activities and individual joints): Subjects participate in 11 weeks of robotic training with the device: BONES (Biomimetic Orthosis Neurorehabilitation for Elbow and Shoulder) , 3 days per week, 1 hour per day with the robotic exercise program.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training

Baseline characteristics by cohort

Measure	Type I Robotic Therapy (Functional Activities Then Individual Joint Exercises) n=10 Participants Robotic group (Type I) Type I Robotic Group (Functional activities and individual joints): Subjects participate in 11 weeks of robotic training with the device: BONES (Biomimetic Orthosis Neurorehabilitation for Elbow and Shoulder), 3 days per week, 1 hour per day with the robotic exercise program involving multiple joints at the same time for the functional activities such as cleaning the window, driving a steering wheel, grocery shopping, etc; and then individual joint exercises focusing on one joint at a time with the individual joint exercises.	Type II Robotic Therapy (Individual Joints Exercises Then Functional Activities) n=10 Participants Robotic group (Type II) Type II Robotic therapy (Individual joints exercises then functional activities): Subjects participate in 11 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program. The robotic exoskeleton assists in arm and hand movements as the patient perform individual joint exercises focusing on one joint at a time; and then functional activities like cleaning the window, driving a steering wheel, grocery shopping, etc for the functional activities.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 7 • n=5 Participants	60 years STANDARD_DEVIATION 7 • n=7 Participants	60 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Post first intervention at 5 weeks, post second intervention at 11 weeks, and 3-month after the completion of the second intervention.

We measured the Box and Blocks Test scores at baseline evaluation, after each intervention, and at the 3-month follow up evaluation. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome.

Outcome measures

Measure	Functional Multi-joint Training Then Individual Joint Training n=10 Participants Subjects participated in 4 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program which focuses on functional multi-joint activities such as cleaning the windows, driving a steering wheel, grocery shopping, etc. Then, subjects performed individual joint exercises focusing on one joint at a time for another 4 weeks with 3 days per week and 1 hour per day with the robot-assisted exercise program.	Individual Joint Training Then Functional Multi-joint Training n=10 Participants Subjects participated in 4 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program which focuses on individual joint exercises, one joint at a time. Then, subjects performed the multi-joint functional training exercises for another 4 weeks with 3 days per week and 1 hour per day focusing on multi-joint activities such as cleaning the windows, driving a steering wheel, grocery shopping, etc.
Box & Blocks Test Baseline evaluation	25 blocks Standard Deviation 11	36 blocks Standard Deviation 14
Box & Blocks Test Post 1st Intervention	29 blocks Standard Deviation 18	42 blocks Standard Deviation 14
Box & Blocks Test Post 2nd Intervention	31 blocks Standard Deviation 11	43 blocks Standard Deviation 13
Box & Blocks Test 3-month follow up evaluation	28 blocks Standard Deviation 5	46 blocks Standard Deviation 9

Adverse Events

Individual Joints

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Functional Multi-Joint Activities

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr David Reinkensmeyer

University of California Irvine

Phone: (949) 824-5218

Email: dreinken@uci.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place