Trial Outcomes & Findings for Dual-task Augmented Reality Treatment for Parkinson's Disease (NCT NCT04634331)

NCT ID: NCT04634331

Last Updated: 2024-09-19

Results Overview

Walking speed (m/s) on a self-paced treadmill during single and dual task conditions

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 51 participants
• Primary outcome timeframe: From baseline assessment to the end of the 8-week training session
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	Traditional Multi-Modal Training A physical therapist will provide 1:1 multi-modal training. Multi-modal training is the simultaneous performance of a motor and a cognitive task (i.e. marching while answering math questions) Traditional Multi-Modal Training: Training administered via a 1:1 physical therapy session	Augmented Reality Multi-Modal Training Multi-modal training will be administered via the Microsoft HoloLens 2 augmented reality head set. Augmented reality allows user to see the real world, and inserts holograms into the environment. For example, the user could see boxes on the ground that they need to step around when walking. The boxes are not real, but rather a hologram that only the user can see. The augmented reality device will instruct the participant on the motor and cognitive task that should be performed simultaneously in a similar manner to the physical therapist in the traditional multi-modal training group. The intervention will be overseen by a physical therapist. Augmented Reality Multi-Modal Training: Training administered via an augmented reality headset.
Overall Study STARTED	24	27
Overall Study COMPLETED	22	25
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Traditional Multi-Modal Training A physical therapist will provide 1:1 multi-modal training. Multi-modal training is the simultaneous performance of a motor and a cognitive task (i.e. marching while answering math questions) Traditional Multi-Modal Training: Training administered via a 1:1 physical therapy session	Augmented Reality Multi-Modal Training Multi-modal training will be administered via the Microsoft HoloLens 2 augmented reality head set. Augmented reality allows user to see the real world, and inserts holograms into the environment. For example, the user could see boxes on the ground that they need to step around when walking. The boxes are not real, but rather a hologram that only the user can see. The augmented reality device will instruct the participant on the motor and cognitive task that should be performed simultaneously in a similar manner to the physical therapist in the traditional multi-modal training group. The intervention will be overseen by a physical therapist. Augmented Reality Multi-Modal Training: Training administered via an augmented reality headset.
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

Dual-task Augmented Reality Treatment for Parkinson's Disease

Baseline characteristics by cohort

Measure	Traditional Multi-Modal Training n=24 Participants A physical therapist will provide 1:1 multi-modal training. Multi-modal training is the simultaneous performance of a motor and a cognitive task (i.e. marching while answering math questions) Traditional Multi-Modal Training: Training administered via a 1:1 physical therapy session	Augmented Reality Multi-Modal Training n=27 Participants Multi-modal training will be administered via the Microsoft HoloLens 2 augmented reality head set. Augmented reality allows user to see the real world, and inserts holograms into the environment. For example, the user could see boxes on the ground that they need to step around when walking. The boxes are not real, but rather a hologram that only the user can see. The augmented reality device will instruct the participant on the motor and cognitive task that should be performed simultaneously in a similar manner to the physical therapist in the traditional multi-modal training group. The intervention will be overseen by a physical therapist. Augmented Reality Multi-Modal Training: Training administered via an augmented reality headset.	Total n=51 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	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Age, Continuous	68.4 years STANDARD_DEVIATION 6.1 • n=5 Participants	69.9 years STANDARD_DEVIATION 6.2 • n=7 Participants	69.2 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	22 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized White	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	27 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline assessment to the end of the 8-week training session

Walking speed (m/s) on a self-paced treadmill during single and dual task conditions

Outcome measures

Measure	Traditional Multi-Modal Training n=22 Participants A physical therapist will provide 1:1 multi-modal training. Multi-modal training is the simultaneous performance of a motor and a cognitive task (i.e. marching while answering math questions) Traditional Multi-Modal Training: Training administered via a 1:1 physical therapy session	Augmented Reality Multi-Modal Training n=25 Participants Multi-modal training will be administered via the Microsoft HoloLens 2 augmented reality head set. Augmented reality allows user to see the real world, and inserts holograms into the environment. For example, the user could see boxes on the ground that they need to step around when walking. The boxes are not real, but rather a hologram that only the user can see. The augmented reality device will instruct the participant on the motor and cognitive task that should be performed simultaneously in a similar manner to the physical therapist in the traditional multi-modal training group. The intervention will be overseen by a physical therapist. Augmented Reality Multi-Modal Training: Training administered via an augmented reality headset.
Gait Velocity End of Treatment 2-Back Dual-Task Walk Speed	1.17 meters/second Standard Error 0.29	1.22 meters/second Standard Error 0.33
Gait Velocity Baseline Single-task Walk Speed	1.20 meters/second Standard Error 0.19	1.22 meters/second Standard Error 0.20
Gait Velocity Baseline Serial 7 Dual-Task Walk Speed	1.03 meters/second Standard Error 0.24	1.07 meters/second Standard Error 0.29
Gait Velocity Baseline Digit Recall Dual-Task Walk Speed	1.05 meters/second Standard Error 0.18	1.09 meters/second Standard Error 0.23
Gait Velocity Baseline Controlled Oral Word Association Dual-Task Walk Speed	1.09 meters/second Standard Error 0.19	1.11 meters/second Standard Error 0.24
Gait Velocity Baseline Stroop Dual-Task Walk Speed	1.11 meters/second Standard Error 0.23	1.19 meters/second Standard Error 0.25
Gait Velocity Baseline 1-Back Dual-Task Walk Speed	1.07 meters/second Standard Error 0.27	1.11 meters/second Standard Error 0.27
Gait Velocity Baseline 2-Back Dual-Task Walk Speed	1.08 meters/second Standard Error 0.27	1.09 meters/second Standard Error 0.29
Gait Velocity End of Treatment Single-task Walk	1.27 meters/second Standard Error 0.19	1.33 meters/second Standard Error 0.25
Gait Velocity End of Treatment Serial 7 Dual-Task Walk Speed	1.12 meters/second Standard Error 0.23	1.22 meters/second Standard Error 0.31
Gait Velocity End of Treatment Digit Recall Dual-Task Walk Speed	1.14 meters/second Standard Error 0.22	1.22 meters/second Standard Error 0.29
Gait Velocity End of Treatment Controlled Oral Word Association Dual-Task Walk Speed	1.17 meters/second Standard Error 0.21	1.22 meters/second Standard Error 0.29
Gait Velocity End of Treatment Stroop Dual-Task Walk Speed	1.19 meters/second Standard Error 0.25	1.27 meters/second Standard Error 0.29
Gait Velocity End of Treatment 1-Back Dual-Task Walk Speed	1.18 meters/second Standard Error 0.26	1.25 meters/second Standard Error 0.30

PRIMARY outcome

Timeframe: From baseline assessment to the end of the 8-week training session

Global score of motor function in Parkinson's disease using the Movement Disorders Society-Unified Parkinson's Disease Rating Scale subscale III (MDS-UPDRS III). Eighteen items scored on a 0-4 scale resulting in a score ranging from 0-72. A higher score (larger number) indicates more motor symptoms.

Outcome measures

Measure	Traditional Multi-Modal Training n=22 Participants A physical therapist will provide 1:1 multi-modal training. Multi-modal training is the simultaneous performance of a motor and a cognitive task (i.e. marching while answering math questions) Traditional Multi-Modal Training: Training administered via a 1:1 physical therapy session	Augmented Reality Multi-Modal Training n=25 Participants Multi-modal training will be administered via the Microsoft HoloLens 2 augmented reality head set. Augmented reality allows user to see the real world, and inserts holograms into the environment. For example, the user could see boxes on the ground that they need to step around when walking. The boxes are not real, but rather a hologram that only the user can see. The augmented reality device will instruct the participant on the motor and cognitive task that should be performed simultaneously in a similar manner to the physical therapist in the traditional multi-modal training group. The intervention will be overseen by a physical therapist. Augmented Reality Multi-Modal Training: Training administered via an augmented reality headset.
MDS-UPDRS III Score Baseline MDS-UPDRS III Score	34.1 score on a scale Standard Deviation 13.1	37.6 score on a scale Standard Deviation 12.3
MDS-UPDRS III Score End of Treatment MDS-UPDRS III Score	34.9 score on a scale Standard Deviation 11.4	36.6 score on a scale Standard Deviation 12.8

PRIMARY outcome

Timeframe: From baseline assessment to the end of the 8-week training session

number of falls in the previous 30 day period

Outcome measures

Measure	Traditional Multi-Modal Training n=22 Participants A physical therapist will provide 1:1 multi-modal training. Multi-modal training is the simultaneous performance of a motor and a cognitive task (i.e. marching while answering math questions) Traditional Multi-Modal Training: Training administered via a 1:1 physical therapy session	Augmented Reality Multi-Modal Training n=25 Participants Multi-modal training will be administered via the Microsoft HoloLens 2 augmented reality head set. Augmented reality allows user to see the real world, and inserts holograms into the environment. For example, the user could see boxes on the ground that they need to step around when walking. The boxes are not real, but rather a hologram that only the user can see. The augmented reality device will instruct the participant on the motor and cognitive task that should be performed simultaneously in a similar manner to the physical therapist in the traditional multi-modal training group. The intervention will be overseen by a physical therapist. Augmented Reality Multi-Modal Training: Training administered via an augmented reality headset.
Fall Frequency Baseline Number of falls	0.5 number of falls Standard Deviation 1.22	0.68 number of falls Standard Deviation 1.14
Fall Frequency End of Treatment Number of Falls	0.64 number of falls Standard Deviation 1.59	0.52 number of falls Standard Deviation 0.71

Adverse Events

Traditional Multi-Modal Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Augmented Reality Multi-Modal Training

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Traditional Multi-Modal Training n=24 participants at risk A physical therapist will provide 1:1 multi-modal training. Multi-modal training is the simultaneous performance of a motor and a cognitive task (i.e. marching while answering math questions) Traditional Multi-Modal Training: Training administered via a 1:1 physical therapy session	Augmented Reality Multi-Modal Training n=27 participants at risk Multi-modal training will be administered via the Microsoft HoloLens 2 augmented reality head set. Augmented reality allows user to see the real world, and inserts holograms into the environment. For example, the user could see boxes on the ground that they need to step around when walking. The boxes are not real, but rather a hologram that only the user can see. The augmented reality device will instruct the participant on the motor and cognitive task that should be performed simultaneously in a similar manner to the physical therapist in the traditional multi-modal training group. The intervention will be overseen by a physical therapist. Augmented Reality Multi-Modal Training: Training administered via an augmented reality headset.
Injury, poisoning and procedural complications Fall	0.00% 0/24 • Adverse events were collected over the 5 month study enrollment for each participant.	3.7% 1/27 • Number of events 1 • Adverse events were collected over the 5 month study enrollment for each participant.

Other adverse events

Measure	Traditional Multi-Modal Training n=24 participants at risk A physical therapist will provide 1:1 multi-modal training. Multi-modal training is the simultaneous performance of a motor and a cognitive task (i.e. marching while answering math questions) Traditional Multi-Modal Training: Training administered via a 1:1 physical therapy session	Augmented Reality Multi-Modal Training n=27 participants at risk Multi-modal training will be administered via the Microsoft HoloLens 2 augmented reality head set. Augmented reality allows user to see the real world, and inserts holograms into the environment. For example, the user could see boxes on the ground that they need to step around when walking. The boxes are not real, but rather a hologram that only the user can see. The augmented reality device will instruct the participant on the motor and cognitive task that should be performed simultaneously in a similar manner to the physical therapist in the traditional multi-modal training group. The intervention will be overseen by a physical therapist. Augmented Reality Multi-Modal Training: Training administered via an augmented reality headset.
Injury, poisoning and procedural complications Fall	0.00% 0/24 • Adverse events were collected over the 5 month study enrollment for each participant.	3.7% 1/27 • Number of events 1 • Adverse events were collected over the 5 month study enrollment for each participant.

Additional Information

Dr. Jay Alberts

Cleveland Clinic

Phone: 216 445-3222

Email: albertj@ccf.org

Results disclosure agreements

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