Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to investigate if combined motor-cognitive training can improve motor and cognitive symptoms in older adults with motoric cognitive risk syndrome. The main questions it aims to answer are:
Researchers will compare virtual reality treadmill training with treadmill training to see if virtual reality treadmill training works to improve motor and cognitive functions in older adults at risk of dementia
Participants will
The objective of this single-blind randomized controlled trial is to compare the effects of combined motor-cognitive training using a virtual reality treadmill with motor training using a conventional treadmill in older adults with Motoric Cognitive Risk (MCR) syndrome. MCR is a geriatric condition characterized by slow gait speed and subjective cognitive complaints. The coexistence of motor and cognitive impairments in individuals with MCR significantly increases their risk of developing dementia. To date, randomized controlled trials investigating active interventions that simultaneously target both motor and cognitive functions remain scarce. This study will examine whether 18 training sessions, delivered over six weeks at a frequency of three 1-hour sessions per week, using a virtual reality treadmill lead to greater improvements in motor and cognitive outcomes compared to conventional treadmill training.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Treadmill Training | Experimental | The virtual reality treadmill training (VRTT) group will complete 18 training sessions over six weeks (three 1-hour sessions per week). Participants will perform prescribed tasks designed to challenge motor, cognitive, and motor-cognitive functions within a VR environment projected onto a screen in front of the treadmill (Fig 1). The VRTT system includes a conventional treadmill with a harness suspension system, camera-based motion capture (Intel RealSense, Santa Clara, CA), and a computer-generated simulation (GaitBetter, Tel Aviv, Israel). The camera tracks the participant's feet movements, which are displayed within the VR environment, allowing participants to see their feet navigating obstacles, pathways, and narrow corridors. Each session will include three walking bouts interspersed with rest breaks, targeting at least 40 minutes of active motor-cognitive training. |
|
| Treadmill Training | Active Comparator | Participants in the treadmill training (TT) intervention will follow a traditional TT program without feedback from the VR system. 70 The focus will be on increasing gait speed and distance, with no motor-cognitive training such as obstacle crossing or cognitive tasks while walking. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Treadmill Training | Behavioral | The Virtual Reality Treadmill Training (VRTT) group will complete 18 training sessions over six weeks (three 1-hour sessions per week). Participants will perform prescribed tasks designed to challenge motor, cognitive, and motor-cognitive functions within a VR environment projected onto a screen in front of the treadmill (Fig 1). The VRTT system includes a conventional treadmill with a harness suspension system, camera-based motion capture (Intel RealSense, Santa Clara, CA), and a computer-generated simulation (GaitBetter, Tel Aviv, Israel). The camera tracks the participant's feet movements, which are displayed within the VR environment, allowing participants to see their feet navigating obstacles, pathways, and narrow corridors. Each session will include three walking bouts interspersed with rest breaks, targeting at least 40 minutes of active motor-cognitive training. |
| Measure | Description | Time Frame |
|---|---|---|
| Dual-task gait speed | 2 trials of 2-minute walking on a 10-meter walkway while completing auditory oddball task | From enrollment to the end of treatment at 6 weeks |
| Cognition | Uniform Data Set (UDS) 4.0 global cognition composite score | From enrollment to the end of treatment at 6 weeks |
| Gait speed | Gait speed on 4-meter walk test (4MWT) | From enrollment to the end of treatment at 6 weeks |
| Cognitive complaints | Self-report of cognitive complaints based on memory item of the Geriatric Depression Scale (GDS): yes - no | From enrollment to the end of treatment at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dual task cost | Motor and cognitive dual task cost defined using ((dual task - single task) / single task) * 100 | From enrollment to the end of treatment at 6 weeks |
| Spatiotemporal gait characteristics |
| Measure | Description | Time Frame |
|---|---|---|
| Real-world physical activity and gait data | Physical activity and gait data collected from activity sensors | From enrollment to the end of treatment at 6 weeks |
| Depression | Scores on the Geriatric Depression Scale (GDS): range 0 - 15; higher score is worse |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
single-blind randomized controlled trial
Not provided
Not provided
Assessors will be blinded to the group allocation
|
| Treadmill Training | Behavioral | Participants in the Treadmill Training (TT) intervention will follow a traditional TT program without feedback from the VR system. 70 The focus will be on increasing gait speed and distance, with no motor-cognitive training such as obstacle crossing or cognitive tasks while walking. |
|
Inertial Motion Units will collect spatiotemporal gait characteristics during single-task and dual-task walking
| From enrollment to the end of treatment at 6 weeks |
| Cognitive domain scores | Uniform Data Set 4.0 (UDS) cognitive domain scores | From enrollment to the end of treatment at 6 weeks |
| P3 event-related potential (ERP) | P3 event-related potential (ERP) extracted from electroencephalography during oddball test | From enrollment to the end of treatment at 6 weeks |
| Mitochondrial function | Mitochondrial functional index collected from blood serum | From enrollment to the end of treatment at 6 weeks |
| From enrollment to the end of treatment at 6 weeks |
| Health-related Quality of life | Scores on Short Form 36 (SF-36): range 0 - 100; higher score is better | From enrollment to the end of treatment at 6 weeks |
| Frailty | Scores on the Evaluative Frailty Index for Physical Activity (EFIPA): range 0 - 1; higher score is worse | From enrollment to the end of treatment at 6 weeks |
| Falls | Self-report of falls via falls diaries | From enrollment to the end of treatment at 6 weeks |
| Resilience | Brief Resilience Scale (BRS): range 6 - 30; higher scores are better | From enrollment to the end of treatment at 6 weeks |