Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000851460
Ethics application status
Approved
Date submitted
23/06/2016
Date registered
29/06/2016
Date last updated
14/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Move to the Music - the effect of music cues on walking in people with 2 types of progressive neurological disorder.
Scientific title
Exercises Using Music Cues To Improve Gait In People With 2 types of Progressive Degenerative Neurological Disorder – Progressive Supranuclear Palsy and Alzheimer’s disease
Secondary ID [1] 289524 0
None
Universal Trial Number (UTN)
U1111-1184-5735
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Progressive Supranuclear Palsy 299231 0
Alzheimer's Disease 299232 0
Condition category
Condition code
Neurological 299239 299239 0 0
Neurodegenerative diseases
Physical Medicine / Rehabilitation 299240 299240 0 0
Physiotherapy
Neurological 299278 299278 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of 8 sessions of systematically progressed exercises/activities synchronised to rhythmic auditory stimuli including music.
The 8 intervention sessions will be no more than 1 hour in duration and will be delivered by experienced physiotherapists two times/week for 4 weeks in participants' own homes.
Each session will consist of 5 Sections of about 8 minutes each including rests (listening to music) as often as needed.
Auditory cues will be set at the comfortable pace cadence from the baseline gait assessment.
1.) Warmup - gentle range of motion exercises
2.) Seated "walking" +/arm swing
3.) Stand and toetap/step
4.) Walk on the Spot
5.) Walk in a straight line
Over the course of the 4 week intervention period the activities may be varied according to participant progress/tolerance.
Variations may include verbal or tactile cues, different musical pieces, auditory cues set at 10% faster than baseline cadence and cue fading with the participant aiming to maintain the rhythmic movement as cue volume is turned down.
Auditory cues will be played through an MP3 player and portable speaker with the volume determined by the participant but capped at a maximum level of 94 dB which has a safe continuous exposure time of one hour.

Independent Practice Sessions
During the first intervention session, each participant will be given an MP3 player and headphones preloaded with about 15 minutes of music (some chosen with reference to personal preference). Participants will be asked to listen to this music for 15 minutes each day of the 4 week intervention period. They will be seated in their own comfortable chair and asked to focus on the rhythm of the music pieces and then move their arms and/or tap their toes to the beat. They will be asked to record their practice sessions on a diary record sheet.
Intervention code [1] 295116 0
Rehabilitation
Intervention code [2] 295148 0
Treatment: Other
Comparator / control treatment
The group with Alzheimer's Disease will serve as the control for the group with Progressive Supranuclear Palsy.
Control group
Active

Outcomes
Primary outcome [1] 298723 0
Change from baseline in self-selected comfortable pace gait velocity will be measured using an 8m long GAITRite electronic mat.
Timepoint [1] 298723 0
Post-intervention (week 5)
Primary outcome [2] 298724 0
Change from baseline in self-selected comfortable pace gait temporospatial variability will be measured using an 8m long GAITRite electronic mat.
Timepoint [2] 298724 0
Post intervention (week 5)
Secondary outcome [1] 325063 0
Change from baseline in mood will be measured using a pictorial happiness scale and the Geriatric Depression scale
Timepoint [1] 325063 0
Post-intervention (week 5)

Eligibility
Key inclusion criteria
A diagnosis of probable Alzheimer's Disease or Progressive Supranuclear Palsy according to consensus criteria determined by the participant's medical specialist.
The ability to walk 50m independently without a gait aid.
Adequate hearing for conversation (including with hearing aids).
The capacity to comprehend instructions for the trial.
Medical cleareance to undertake physical activity of light to moderate intensity.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are limited cardiac or pulmonary capacity and diagnosis with any neurologic or musculoskeletal comorbidity or pain which would affect gait.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Degree of change in measures from baseline to post-intervention will be compared between the 2 groups.
This study is a feasibility trial with one of the objectives being to determine recruitment rates over an 8 month time period.
Participant numbers were determined as a guide following input from participant referral sources.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/06/2016
Actual
29/06/2016
Date of last participant enrolment
Anticipated
17/11/2017
Actual
25/09/2017
Date of last data collection
Anticipated
22/12/2017
Actual
6/11/2017
Sample size
Target
20
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 13438 0
3086 - La Trobe University
Recruitment postcode(s) [2] 13439 0
3111 - Donvale

Funding & Sponsors
Funding source category [1] 293901 0
Charities/Societies/Foundations
Name [1] 293901 0
Parkinson's Victoria
Country [1] 293901 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive, Bundoora, VIC. 3086
Country
Australia
Secondary sponsor category [1] 292725 0
None
Name [1] 292725 0
Address [1] 292725 0
Country [1] 292725 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295316 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 295316 0
Ethics committee country [1] 295316 0
Australia
Date submitted for ethics approval [1] 295316 0
11/03/2016
Approval date [1] 295316 0
14/04/2016
Ethics approval number [1] 295316 0
HEC16-016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66858 0
Dr Joanne Wittwer
Address 66858 0
Department of Physiotherapy,
School of Allied Health
La Trobe University,
Kingsbury Drive,
Bundoora, VIC. 3086
Country 66858 0
Australia
Phone 66858 0
+61 3 94795808
Fax 66858 0
+61 3 94792552
Email 66858 0
[email protected]
Contact person for public queries
Name 66859 0
Joanne Wittwer
Address 66859 0
Department of Physiotherapy,
School of Allied Health
La Trobe University,
Kingsbury Drive,
Bundoora, VIC. 3086
Country 66859 0
Australia
Phone 66859 0
+61 3 94795808
Fax 66859 0
+61 3 94792552
Email 66859 0
[email protected]
Contact person for scientific queries
Name 66860 0
Joanne Wittwer
Address 66860 0
Department of Physiotherapy,
School of Allied Health
La Trobe University,
Kingsbury Drive,
Bundoora, VIC. 3086
Country 66860 0
Australia
Phone 66860 0
+61 3 94795808
Fax 66860 0
+61 3 94792552
Email 66860 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA home-based, music-cued movement program is feasible and may improve gait in progressive supranuclear palsy.2019https://dx.doi.org/10.3389/fneur.2019.00116
EmbaseHome-Based Gait Training Using Rhythmic Auditory Cues in Alzheimer's Disease: Feasibility and Outcomes.2020https://dx.doi.org/10.3389/fmed.2019.00335
N.B. These documents automatically identified may not have been verified by the study sponsor.