On-line Cognitive Training for Mild Cognitive Impairment in Parkinson's Disease: a Randomized Single-blind Study Using Wearing Sensors Technology
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Università degli Studi di Brescia
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Trial making B performance, total score (0-240 seconds)
- Last Updated
- 6 years ago
Overview
Brief Summary
Application of online cognitive training in patients affected by Parkinson's disease and mild cognitive impairment. The treatment consists of a 6-week on-line cognitive training preceded and followed by neurological, neuropsychological and motor assessment.
Detailed Description
At the recruitment, participants will undergo a neurological visit, a neuropsychology assessment (2 tests for each considered cognitive domain: memory, attention, visuospatial, executive function, language) and a motor assessment with wearing sensors under supervised conditions. In the treatment arm only, patients will have the Neuronation application installed on their personal technology device (smartphone or tablet) and are asked to complete 4 training session three times a week. Each session is composed of 5 exercises from one out of 4 cognitive domains: Memory, Attention, Speed and Reasoning. The training is tailor made, the complexity of the exercises is adjusted online, based on the patient's performance. Participants are re-assessed at the end of the 6-week cognitive training (T1) to find out its effects on cognition and motor ability. The same assessment is administered also after 1 (T2) and 3 (T3) months from the end of the cognitive training to test long-term effects.
Investigators
Andrea Pilotto
Neurology Department Director
Università degli Studi di Brescia
Eligibility Criteria
Inclusion Criteria
- •Ease of use of at home internet connection
- •Active presence of a caregiver to help with the use of the App
- •Sufficient physical ability to use a technological device
- •Signature of informed consent
Exclusion Criteria
- •Presence of systemic pathologies potentially responsible for cognitive deficits
- •Presence of pathologies of the Central Nervous system potentially associated with cognitive deficits
- •No access to internet connection
- •Cognitive rehabilitation within the previous 6 months
- •Major depression (assessed by Beck Depression Inventory at baseline)
Outcomes
Primary Outcomes
Trial making B performance, total score (0-240 seconds)
Time Frame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Trial making B performance, total score (0-240 seconds)
Parkinson´s disease Quality of life questionnire (PDQ-39) (0-117 points)
Time Frame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
PDQ-39 will be assessed in patients
Supervised gait performance dual task gait
Time Frame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Step variability using wearing sensors technology in one-minute supervised dual task walking
Sum of total Z-score of cognitive assessment (-30 to 30)
Time Frame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Sum of total Z-score of cognitive assessment (-30 to 30)
Supervised gait performance normal gait
Time Frame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Step variability using wearing sensors technology in one-minute supervised walking
Quality of life - caregivers
Time Frame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Caregiver Burden will be assessed with Dyadic relationship scale
Secondary Outcomes
- Unified parkinson´s disease Rating Scale part 3 (0-132 points)(Changes between baseline, immediately after the end of intervention, after 1 month and 3 monthss)
- Instability measures(Changes between baseline, immediately after the end of intervention, after 1 month and 3 months)
- Turning performances(Changes between baseline, immediately after the end of intervention, after 1 month and 3 months)
- Dual task performance in circular walking (0-240 seconds)(Changes between baseline, immediately after the end of intervention, after 1 month and 3 months)
- Short Physical performance battery (SPPB), total time (0- 60 seconds)(Changes between baseline, immediately after the end of intervention, after 1 month and 3 months)