The effects of face masks on walking adaptability in people with Parkinson’s disease and multiple sclerosis: A crossover study

Phase 2

Conditions: G20
G35
Parkinson disease
Multiple sclerosis

Registration Number: DRKS00030207

Lead Sponsor: eurologisches Rehabilitationszentrum Godeshöhe

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 50

Inclusion Criteria

• diagnosed either by the treating physician or by a neurologist with either Parkinson's disease or multiple sclerosis
• willing to provide informed consent
• able to conduct the C-Gait Test
• inpatient of the Neurological Rehabilitation Center Godeshoehe

Exclusion Criteria

• MOCA score < 17
• existing contraindications to using the C-Mill+VR treadmill: A severe cognitive, visual or hearing impairment where the patient is not able to follow the instructions of the therapist; More than 135 kg total bodyweight; More than 2.00 meter body height; Open skin lesion or bandage in the area of harness contact; < FAC 2; Severe reduced bone density; Spinal instability or unstable fractures; Severe vascular disorders or cardiac abnormalities that affect the ability to exercise safely; Running < FAC 5
• other neurological or psychiatric illnesses that influence the ability to provide informed consent, understand the testing procedures, compromise safety during data collection or are known to influence motor functions
• insufficient knowledge of German hindering the ability to follow instructions and tests
• uncorrected visual or auditory impairments

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is the overall performance of the C-Gait Test (composite score, calculated as Mean C-Gait scores on high level + C-Gait score for the cognitive performance task). This outcome parameter will be compared per condition (1: with face mask, 2: without face mask)

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints including performance of the seven C-Gait subtests (calculated as Difficulty level x 2 x Performance (%) / 100), as well as performance (duration) of the four field tests (10 Meter Walk test, Timed Up-and-Go test, Timed Up-and Go test in dual task (serial 3s starting from 100) and Stair ascent/Stair Descent).