Music-assisted treadmill training in the therapy of Parkinson's disease
Organizational Data
- DRKS-ID:
- DRKS00017687
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2019-09-25
- Last update in DRKS:
- 2023-02-07
- Registration type:
- Prospective
Acronym/abbreviation of the study
MATT study
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
Parkinson’s Disease (PD) is one of the main neurodegenerative disease in Germany and in western industry nations with increasing number of patients due to the demographic change. In the course of the disease PD patients suffer from motor and non-motor symptoms. Only a limited number of pharmacotherapies for the symptomatic treatment of PD patients are available and so is the invasive deep brain stimulation (DBS), which is limited to a selected group of patients. Inducing an urgent need for alternative, non-pharmacologic therapy options. Motor and cognitive therapies are established treatments, however in the usual care routines they are applied independent (if at all) from on another even though a growing understanding of motor function and cognition as linked entities exists. Furthermore patient’s motivation for long-term adherence can be a challenge in progressive disease. Treadmill training and cueing are successfully applied in routine care of PD patients to improve gait. Patients consider the training with musically auditive cues as especially motivating. A music assisted gait training showed better effects than a usual treadmill training. However, these studies mainly focused on motor functional outcomes, so that a remaining research interest exists to examine the possible effects on cognition. Furthermore, studies rarely include patient-centered outcomes, so that the current project aims at evaluation these. Additionally there is little evidence about the mid-term effects of a music-assisted treadmill training so that these will be evaluated as well. In the current pilot-project with a randomized controlled design and follow-up telephone interview after six weeks, we aim at the evaluation of feasibility as well as short- and mid-term effects of a music-assisted treadmill training on cognition. Furthermore the patient-centered outcomes of mood, motivation, fatigue, and fun will be compared to an usual ergometer training.
Health condition or problem studied
- ICD10:
- G20 - Parkinson disease
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 20 min music assisted treadmill training plus regular motor and cognitive rehabilitation therapy for 8 training days
- Arm 2:
- 20 min ergometertraining plus regular motor and cognitive rehabilitation therapy for 8 training days
Endpoints
- Primary outcome:
- Cognition - Overall cognition (MoCA) - Alertness (TAP) - selective Attention (TAP) - reaction time (WTS, RT-S5) - Inhibition (TAP) - cognitive flexibility (TAP; TMT B/A) - word fluency (RWT) - short-term memory (number and Digit span of WMS-R; visual reproduction of WMS-R) - working memory (number and Digit span of WMS-R) - mentale rotation (LPS-2, Subtest 7) - visual scanning (TAP, TMT- A) - learning strateges (CVLT; TOL-D)
- Secondary outcome:
- Motor Function - gros motor function: Fist Closure Frequency - fine motor function: NHPT - Balance/ risk for falls: BBS; TUG; TUG+DT - gait: 10mGT - Freezing: FoGQ - functional independence: FIM Ability to sychronize Motivation, mood, fatigue und fun while training Disease severity (H&Y; UPDRS) Depression (GDS) Quality of life (PDQ-39; EQ-5D) Activity level (IPAQ) Fatigue (PFS- 16)
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Neurologisches Rehabilitationszentrum Godeshöhe e.V. Bonn- Bad Godesberg
Recruitment period and number of participants
- Planned study start date:
- 2019-10-01
- Actual study start date:
- 2019-09-26
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2022-11-15
- Target Sample Size:
- 70
- Final Sample Size:
- 70
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 110 Years
- Additional Inclusion Criteria:
- - Patients with Parkinson's disease - no further neurological or psychiatric disease, that interferes with study participation - no hint at a medium severe depression(cut-off: < 10 Points on Geriatric Depression Scale) - no other disease (cardiologic or orthpedic), that interferes with study participation - undisturbed or sufficiently corrected vision and hearing - Participant speaks German - Patient can provide informed consent (cut-off: Montreal Cognitive Assessment (MoCA) > 17 points; Freitas et al., 2014) - Patient can follow therapeutic instructions - Patient provides written consent for study participation - scheduled stay of at least 14 days at neurological rehabilitations center Godeshöhe e.V.
Exclusion Criteria
- severe disturbtion of vigilance, of speech or psychiatric, which interfere with understanding of study aims and/ or instructions, and decrease safety during - daily uncontrolled changes in medication or Stimulation Settings, which would decrease safety
Addresses
Primary Sponsor
- Address:
- Medizinische Psychologie | Neuropsychologie und Gender Studies Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)Prof. Dr. rer. nat. Elke KalbeKerpenerstr. 6250937 KölnGermany
- Telephone:
- +49 221 478-6669
- Fax:
- +49 221 478-3420
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://neurologie-psychiatrie.uk-koeln.de/medizinische-psychologie
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Medizinische Psychologie | Neuropsychologie und Gender Studies Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)Prof. Dr. rer. nat. Elke KalbeKerpenerstr. 6250937 KölnGermany
- Telephone:
- +49 221 478-6669
- Fax:
- +49 221 478-3420
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://neurologie-psychiatrie.uk-koeln.de/medizinische-psychologie
Contact for Public Queries
- Address:
- Medizinische Psychologie | Neuropsychologie und Gender Studies Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)MSc Mareike GooßesKerpenerstr. 6250937 KölnGermany
- Telephone:
- +49 221 478-96250
- Fax:
- +49 221 478-3420
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://neurologie-psychiatrie.uk-koeln.de/medizinische-psychologie.
Principal Investigator
- Address:
- Medizinische Psychologie | Neuropsychologie und Gender Studies Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)Prof. Dr. rer. nat. Elke KalbeKerpenerstr. 6250937 KölnGermany
- Telephone:
- +49 221 478-6669
- Fax:
- +49 221 478-3420
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://neurologie-psychiatrie.uk-koeln.de/medizinische-psychologie
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Medizinische Psychologie | Neuropsychologie und Gender Studies und Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)Kerpener Str. 6250937 KölnGermany
- Telephone:
- +49 221 478-6669
- Fax:
- +49 221 478-3420
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://neurologie-psychiatrie.uk-koeln.de/medizinische-psychologie
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät der Universität zu KölnGleueler Str. 26950935 KölnGermany
- Telephone:
- +49-221-478 82900
- Fax:
- +40-221-478 82905
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-06-13
- Ethics committee number:
- 19-1291
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-07-15
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry