NCT04872153

Brief Summary

This pilot trial aims to evaluate the feasibility and effectiveness of a technology-based intervention for cognitive-motor training in rehabilitation clinics with geriatric, neurological and cardiac patients. The primary objective of this pilot study is to evaluate the feasibility of exergame-based cognitive-motor training in in-patient rehabilitation settings. The secondary objective of this pilot trial is to evaluate the effectiveness of an expanded rehabilitation treatment (combining exergame training with conventional care) on physical and cognitive functioning in different patient groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2021

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

17 days

First QC Date

March 29, 2021

Last Update Submit

December 8, 2022

Conditions

RehabilitationCardiovascular DiseasesGeriatric PatientsParkinson Disease

Keywords

exergamemotor-cognitive trainingfeasibilityrehabilitation

Outcome Measures

Primary Outcomes (7)

  • Adverse Events

    Related and un-related adverse events during the pre-post assessments as well as during each training session will be registered

    Adverse events are assessed during the data collection period, an average of 3 to 4 weeks.

  • Attrition rate

    Number of participants lost during the trial will be recorded (drop-outs in both groups)

    The attrition rate is assessed during the data collection period, an average of 3-4 weeks.

  • Adherence rate

    Percentage of the number of attended training sessions in relation to the number of planned training sessions

    The adherence rate is assessed for all training sessions during the intervention period, an average of 3-4 weeks.

  • System Usability Scale (SUS)

    Participants of the intervention group will receive a survey form at the end of the intervention period regarding usability of the device used for the delivery of the exergame training (Dividat Senso)

    The SUS is completed at the post-measurement by the intervention group. The survey lasts 2 minutes.

  • Nasa Task Load Index (NASA-TLX)

    The NASA-TLX is a self-report, multidimensional assessment tool that rates perceived workload in order to assess a task, a system, or other aspects of performance (in this case the DIVIDAT exergames). It contains five subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort and Frustration. A score from 1-100 is calculated based by averaging all answers to all questions.

    The NASA-TLX is assessed after each training sessions during the intervention period. The survey lasts 1-2 minutes.

  • User Experience

    A questionnaire with (self-developed) questions regarding perceived enjoyment during training, perceived positive effects, intention to use after study's end etc. will be filled out by the intervention group

    The questionnaire is completed at the post-measurement by the intervention group. The survey lasts 2 minutes.

  • Training motivation

    Average training motivation based on motivation question in each session (Scale 1-5) answered by patients.

    The question is assessed before each training session during the intervention period, an average of 3-4 weeks..

Secondary Outcomes (8)

  • Changes in psychomotor speed

    Assessment takes place at pre- and post-measurement within the two days after entry respectively before discharge. The 6-RTT lasts 5 minutes.

  • Changes in mental flexibility

    Assessment takes place at pre- and post-measurement within the two days after entry respectively before discharge. The TMT lasts ca. 10 minutes.

  • Changes in inhibitory control

    Assessment takes place at pre- and post-measurement within the two days after entry respectively before discharge. The test lasts 10 minutes.

  • Changes in selective attention

    Assessment takes place at pre- and post-measurement within the two days after entry respectively before discharge. The Go/No-Go lasts 5 minutes.

  • Changes in functional mobility

    Assessment takes place at pre- and post-measurement within the two days after entry respectively before discharge. The TUG lasts 2 minutes.

  • +3 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

The patients allocated to the intervention group will conduct simultaneously combined cognitive-motor training in form of exergames using the Dividat Senso in addition to the standard rehabilitation treatment plan. Both the Dividat Senso and the training games are specifically developed considering the needs and requirements of older adults but also clinicians/therapists.

Behavioral: Dividat Senso Exergames

Control Group

NO INTERVENTION

The patients of the control group follow the standard rehabilitation treatment plan including: 3x 30min physiotherapy, 8x 30min group therapy, 3x 45min group therapy (group therapy includes body- focused therapy, mindfulness therapy, respiratory therapy, gymnastics, hiking etc.)

Interventions

Dividat Senso ExergamesBEHAVIORAL

The intervention period in the rehabilitation setting will be equal to the length of the stay in the rehabilitation clinic (between 2-3 weeks, according to each cantonal/regional regulations and insurance coverage) and will include short daily training sessions using the Senso (5x/week à 10- 15min), resulting in 15 to 20 training sessions in total. Each session contains various combinations of the Dividat exergames (each of the games lasts around 2-3min).

Intervention Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with prescription for rehabilitation\*
  • ≥ 50 years old
  • Able to score ≥ 20 at the Mini Mental State Examination (MMSE)
  • Able to provide a signed informed consent
  • Physically able to stand for at least 3min without external support (self-report)

You may not qualify if:

  • Mobility or cognitive limitations or comorbidities which impair the ability to use the training games and overall system
  • Conservatively treated osteoporotic fractures
  • Previous or current major psychiatric illness (e.g. schizophrenia, bipolar disorder, recurrent major depression episodes)
  • History of drugs or alcohol abuse
  • Terminal illness
  • Severe sensory impairments (mainly visual, auditory, color blindness)
  • Insufficient knowledge of German to understand the instructions/games
  • \*In the rehabilitation clinics involved as study centres, mainly persons suffering from cardiovascular diseases (clinic Seewis), persons suffering from neurological diseases (esp. Parkinson's Disease according to the United Kingdom Brain Bank criteria) (clinic Zihlschlacht) and geriatric patients (clinic Dussnang) will be included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rehaklinik Dussnang

Dussnang, Thurgau, 8374, Switzerland

Location

Rehaklinik Zihlschlacht

Zihlschlacht-Sitterdorf, Thurgau, 8588, Switzerland

Location

Related Publications (3)

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

    PMID: 38588457DERIVED

  • Jaggi S, Wachter A, Adcock M, de Bruin ED, Moller JC, Marks D, Schweinfurther R, Giannouli E. Feasibility and effects of cognitive-motor exergames on fall risk factors in typical and atypical Parkinson's inpatients: a randomized controlled pilot study. Eur J Med Res. 2023 Jan 16;28(1):30. doi: 10.1186/s40001-022-00963-x.

    PMID: 36647177DERIVED

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PMID: 36602886DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesParkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Eling De Bruin, Prof. Dr.

    ETH Zurich - Institute of Human Movement Sciences and Sport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 29, 2021

First Posted

May 4, 2021

Study Start

January 13, 2021

Primary Completion

January 30, 2021

Study Completion

January 30, 2021

Last Updated

December 9, 2022

Record last verified: 2022-12

Locations

CH(2)