PEMOCS: Personalized Motor-cognitive Training in Chronic Stroke

NCT05524727 | Unknown

• 1 other identifier: 2022-0614
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

Brief Summary

In Switzerland, approximately 20'000 persons suffer a stroke each year. Despite carefully considered rehabilitation programs, full recovery is achieved only in a small proportion of stroke survivors (www.swissheart.ch). Studies suggest that motor-cognitive trainings can improve gait, balance, and mobility in chronic stoke survivors. However, little is known about the effect of motor-cognitive trainings on cognitive functioning in chronic stroke. The aim of this study is to evaluate the effects of a motor-cognitive training added to usual care compared to usual care alone on cognitive functions, single- and dual-task mobility, gait and health-related quality of life. In this single-blind RCT, 38 participants will be allocated randomly to either the intervention group (usual care + motor-cognitive training by means of an exergame for 12 weeks, 2x/week for 30-40 minutes) or the control group (usual care only). Both groups will attend three assessments, at baseline, post-intervention (12 weeks after baseline), and at follow-up (24 weeks after baseline). Global cognitive functioning will be the primary endpoint and a linear mixed model will be used for analysis. Motor-cognitive trainings, especially exergames, bear the potential for further development of innovative long-term rehabilitation solutions for chronic stroke survivors. Cognitive deficits are a common unmet need restricting daily activities mentioned by chronic stroke survivors. Exergame training following personally tailored progression to generate optimal training load may help addressing this unmet need. Therefore, this study will contribute to the on-going research objective on how to improve the long-term care of stroke patients.

Conditions

Stroke

Keywords

cognition; gait; mobility; training; chronic stroke; rehabilitation; virtual reality

Outcome Measures

Primary Outcomes (1)

• Change of Montreal Cognitive Assessment Score

  Widely used screening tool and cognitive outcome in neurological patients including stroke

  week 0, week 12 and week 24

Secondary Outcomes (9)

• Change of Stroke Impact Scale 3.0 Score

  week 0, week 12 and week 24

• Change of Simple Reaction Test Parameters

  week 0, week 12 and week 24

• Change of Trail Making Test A & B Parameters

  week 0, week 12 and week 24

• Change of Stroop Interference Test Parameters

  week 0, week 12 and week 24

• Change of N-back test Parameters

  week 0, week 12 and week 24

Other Outcomes (6)

• Compliance Rate

  week 12

• Adherence Rate

  week 12

• Perceived Motor-Cognitive Task Difficulty

  twice per week, week 0-12

Study Arms (2)

Intervention Group

EXPERIMENTAL

Usual care + concept-guided, personalized, motor-cognitive training by means of an exergame

Other: Concept-guided, personalized, motor-cognitive training by means of an exergame

Control Group

NO INTERVENTION

Usual care only

Interventions

Concept-guided, personalized, motor-cognitive training by means of an exergame OTHER

12 weeks, two times per week for 30-40min

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\> 18 years) with chronic stroke (≥ 6 months post-stroke)
• Stroke: ischemic or haemorrhagic
• Able to stand for 3 minutes and walk 10 meters, functional ambulation category ≥ 3
• Able to follow a two-stage command
• Able to give informed consent as documented by signature

You may not qualify if:

• Unable or not willing to give informed consent
• Other neurological diseases (e.g. Parkinson's Disease, multiple sclerosis), except cognitive deficits or dementia
• Clinical contra-indications for the study intervention
• Unable to follow the study intervention or the test for the primary endpoint (MoCA), e.g. due to a neglect, aphasia or other language problems
• Overlapping enrolment in another clinical trial

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (3)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8400, Switzerland

Location

Ambulante Reha Triemli Zürich

Zurich, 8063, Switzerland

Location

University Hospital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (2)

• Huber SK, Knols RH, Held JPO, Betschart M, Gartmann S, Nauer N, de Bruin ED. PEMOCS: effects of a concept-guided, PErsonalized, MOtor-Cognitive exergame training on cognitive functions and gait in chronic Stroke-a randomized, controlled trial. Front Aging Neurosci. 2025 Mar 13;17:1514594. doi: 10.3389/fnagi.2025.1514594. eCollection 2025.

  PMID: 40182756 DERIVED

• Huber SK, Knols RH, Held JPO, Betschart M, de Bruin ED. PEMOCS: Evaluating the effects of a concept-guided, PErsonalised, MOtor-Cognitive exergame training on cognitive functions and gait in chronic Stroke-study protocol for a randomised controlled trial. Trials. 2024 Jul 4;25(1):451. doi: 10.1186/s13063-024-08283-7.

  PMID: 38965612 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: September 1, 2022
• Study Start: September 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

CH (3)