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=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 6.1 • n=99 Participants
|
69.9 years
STANDARD_DEVIATION 6.2 • n=107 Participants
|
69.2 years
STANDARD_DEVIATION 6.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
27 participants
n=107 Participants
|
51 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From baseline assessment to the end of the 8-week training sessionWalking 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 1-Back Dual-Task Walk Speed
|
1.18 meters/second
Standard Error 0.26
|
1.25 meters/second
Standard Error 0.30
|
|
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
|
PRIMARY outcome
Timeframe: From baseline assessment to the end of the 8-week training sessionGlobal 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
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
|
|
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
|
PRIMARY outcome
Timeframe: From baseline assessment to the end of the 8-week training sessionnumber 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place