Feasibility of a cognitive-motor balance training (StepIt) for people with Parkinson's disease in an inpatient rehabilitation setting

Feasibility of a cognitive-motor balance training (StepIt) for people with Parkinson's disease in an inpatient rehabilitation setting - StepIt

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027558

Enrollment

Registered

2022-01-06

Start date

2022-04-26

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease (idiopathic parkinson syndrom) ICD-10-GM G20.- G20

Interventions

Group 1: After the baseline assessment study-participants will receive 30 minutes one-on-one StepIt training sessions, daily, for two weeks (30 min/ day for 10 days = 5 hours of training). For the Ste

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Persons with Parkinson’s disease; A degree of illness corresponding to Hoehn & Yahr stage I-IV; No conflicting neurological or psychiatric illness that prevent study participation; No other conflicting illness (e.g. cardiac or orthopedic) that would not allow training participation; Unimpaired or corrected vision and hearing; Participants are native German speakers or have a sufficient level of German to understand test and training instructions; Participant is able to follow instructions; Participant is able and willing to provide the written informed consent

Exclusion criteria

Exclusion criteria: A degree of illness corresponding to Hoehn & Yahr stage V; Severely impaired vigilance, speech, and mental health, that conflict with comprehension of the study protocol, test or training instructions or the provision of informed consent; Severe fluctuations of medication or variations in DBS settings that conflict with training safety; Cardiac and / or orthopedic diseases contraindicated to participate in training

Design outcomes

Primary

Measure	Time frame
1. Acceptance, adherence and safety of this training in the inpatient rehabilitation setting 1a. Inclusion-rate: % of participants in relation to eligible patients 1b. Adherence-rate: % of completed trainings in relation to scheduled trainings 1c. Completion-rate: % of participants who completed = 80% of training in relation to all participants 1d. Adverse events: Falls/ almost falls in the direct and indirect context of the StepIt training), terminations of training due to cognitive and/ or motor exhaustion or training-induced pain or unwell-being 2. Usability and user experience by pwPD 2a. Usability of the training: Evaluated by participants applying an adapted form of the Subject Usability Scale (aSUS) 2b. Evaluation of the relevance of the StepIt training (Likert-Scales) to achieve personal rehabilitation goals (defined at the beginning of the rehabilitation with the Goal Attainment Scale, GAS) 2c. Subjectively perceived joy in the overall training: Physical Activity Enjoyment Scale (PACES) 2d. Subjectively perceived joy in each training session: Visual Analogue Scala (VAS) 2e. Subjectively perceived positive training-effects: self-developed questionnaire 2f. Intention to continue training after the end of the study: self-developed questionnaire 2g. Subjectively perceived cognitive and motor load/ demand during training: NASA Task Load Index (NASA-TXL) 3. Exercise performance 3a. Improvement: Baseline level compared to the highest level achieved 3b. Training load: Number of learned stepping sequences (per session and in overall training) 3c. Speed-error-rate: Errors resulting from speed (yes/ no) 3d. Accuracy-error-rate: Errors caused by stepping outside the correct field	—

Measure

Time frame

1. Acceptance, adherence and safety of this training in the inpatient rehabilitation setting 1a. Inclusion-rate: % of participants in relation to eligible patients 1b. Adherence-rate: % of completed trainings in relation to scheduled trainings 1c. Completion-rate: % of participants who completed = 80% of training in relation to all participants 1d. Adverse events: Falls/ almost falls in the direct and indirect context of the StepIt training), terminations of training due to cognitive and/ or motor exhaustion or training-induced pain or unwell-being 2. Usability and user experience by pwPD 2a. Usability of the training: Evaluated by participants applying an adapted form of the Subject Usability Scale (aSUS) 2b. Evaluation of the relevance of the StepIt training (Likert-Scales) to achieve personal rehabilitation goals (defined at the beginning of the rehabilitation with the Goal Attainment Scale, GAS) 2c. Subjectively perceived joy in the overall training: Physical Activity Enjoyment Scale (PACES) 2d. Subjectively perceived joy in each training session: Visual Analogue Scala (VAS) 2e. Subjectively perceived positive training-effects: self-developed questionnaire 2f. Intention to continue training after the end of the study: self-developed questionnaire 2g. Subjectively perceived cognitive and motor load/ demand during training: NASA Task Load Index (NASA-TXL) 3. Exercise performance 3a. Improvement: Baseline level compared to the highest level achieved 3b. Training load: Number of learned stepping sequences (per session and in overall training) 3c. Speed-error-rate: Errors resulting from speed (yes/ no) 3d. Accuracy-error-rate: Errors caused by stepping outside the correct field

—

Secondary

Measure	Time frame
Cognition: global cognition (Montreal Cognitive Assessment), attention (Test of Attentional Performance (TAP), subtest alertness), executive functions (inhibition: TAP Go/NoGo subtest, flexibility: TAP flexibility subtest, verbal and non-verbal working memory: digit and spatial span of the revised version of the Wechsler Memory Scale (WMS-R)); motor function: mobility (Mini-BEST, Timed Up and Go Test without and with dual task, 10m walk test), functional independance (Functional independance Measure, FIM), motor deficit (Unified Parkinson's disease Rating Scale (MDS-UPDRS), motor part III); sociodemographic and clinical data: age, gender, education level, bodyweight, height, profession, marital status, living situation, time since diagnosis, deep brain stimulation (DBS), (time since DBS surgery), degree of illness, mood, quality of life, physical activity level, fatigue, freezing, subjective fear of falling	—

Measure

Time frame

Cognition: global cognition (Montreal Cognitive Assessment), attention (Test of Attentional Performance (TAP), subtest alertness), executive functions (inhibition: TAP Go/NoGo subtest, flexibility: TAP flexibility subtest, verbal and non-verbal working memory: digit and spatial span of the revised version of the Wechsler Memory Scale (WMS-R)); motor function: mobility (Mini-BEST, Timed Up and Go Test without and with dual task, 10m walk test), functional independance (Functional independance Measure, FIM), motor deficit (Unified Parkinson's disease Rating Scale (MDS-UPDRS), motor part III); sociodemographic and clinical data: age, gender, education level, bodyweight, height, profession, marital status, living situation, time since diagnosis, deep brain stimulation (DBS), (time since DBS surgery), degree of illness, mood, quality of life, physical activity level, fatigue, freezing, subjective fear of falling

—

Countries

Germany

Contacts

Public ContactMareike Eschweiler

Neurologisches Rehabilitationszentrum "Godeshöhe" e.V. Abteilung für Therapiewissenschaften

m.eschweiler@godeshoehe.de+49228381559

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026