Sing For Your Saunter Part 2 R33 (SFYS2)

The Washington University

Status and phase: Active, not recruiting; Phase 2

Conditions: Parkinson Disease

Treatments: Behavioral: Self Cueing Training; Behavioral: External Cueing Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06115382

202309088

Details and patient eligibility

About

The goal of this clinical trial is to compare to rhythm-based walking interventions to enhance gait in people with Parkinson's disease. The main questions it aims to answer are:

• How does rhythm-based training influence walking performance?
• How does brain activity change following rhythm-based training? Participants will perform walking to music and walking while singing, and will train on the use of these rhythms for 12 weeks. The investigators will compare the effects of training with music to training with singing.

Enrollment: 74 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. at least 30 years of age
2. diagnosis of idiopathic, typical Parkinson disease according to the UK Brain Bank Criteria
3. Hoehn & Yahr stages 2-3 (mild to moderate disease severity)
4. evidence of walking impairment (score at least 1 on gait item of MDS_UPDRS)

4) stable on all Parkinson disease medications for at least 2 months prior to study entry 5) willing and able to provide informed consent 6) right-handed

Exclusion criteria

1. diagnosis of any other neurological condition
2. a score of 2 or greater on item # 3 on the freezing of gait questionnaire
3. significant cognitive impairment
4. unstable medical or concomitant illnesses or psychiatric conditions which, in the opinion of the investigators, would preclude successful participation
5. cardiac problems that interfere with ability to safely participate
6. orthopedic problems in the lower extremities or spine that may limit walking
7. contraindications for magnetic resonance imaging
8. unable to walk for 10 continuous minutes independently
9. left-handed
10. uncontrolled tremor or dyskinesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Self cueing

Experimental group

Description:

Self-cueing training using singing, one hour sessions twice weekly for 12 weeks.

Treatment:

Behavioral: Self Cueing Training

External cueing

Experimental group

Description:

External cueing using music, one hour sessions twice weekly for 12 weeks.

Treatment:

Behavioral: External Cueing Training