Trial Outcomes & Findings for Genetic Influences on Response to Gait Rehabilitation in Parkinson's Disease (NCT NCT03607695)

NCT ID: NCT03607695

Last Updated: 2021-10-27

Results Overview

The investigators will use the APDM Movement Monitoring system to assess gait speed (m/s) during straight-line walking as a measure of gait function.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: measured at baseline, 2 weeks, 10 weeks and 16 weeks
• Results posted on: 2021-10-27

Participant Flow

Participant milestones

Measure	Gait Training 1 hour walking exercise on a treadmill Gait training: Walking on a treadmill and receiving verbal cues to improve gait quality
2 Week STARTED	19
2 Week COMPLETED	19
2 Week NOT COMPLETED	0
10 Week STARTED	19
10 Week COMPLETED	18
10 Week NOT COMPLETED	1
16 Week STARTED	18
16 Week COMPLETED	16
16 Week NOT COMPLETED	2

Reasons for withdrawal

Measure	Gait Training 1 hour walking exercise on a treadmill Gait training: Walking on a treadmill and receiving verbal cues to improve gait quality
10 Week Local and institutional restrictions on research enacted due to COVID-19 pandemic	1
16 Week Local and institutional restrictions on research enacted due to COVID-19 pandemic	2

Baseline Characteristics

Genetic Influences on Response to Gait Rehabilitation in Parkinson's Disease

Baseline characteristics by cohort

Measure	Gait Training n=19 Participants 1 hour walking exercise on a treadmill Gait training: Walking on a treadmill and receiving verbal cues to improve gait quality
Age, Continuous	66.5 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: measured at baseline, 2 weeks, 10 weeks and 16 weeks

Population: Three participants did not complete the 16 week (follow-up) visit due to local and institutional restrictions on research implemented early in the COVID-19 pandemic.

The investigators will use the APDM Movement Monitoring system to assess gait speed (m/s) during straight-line walking as a measure of gait function.

Outcome measures

Measure	Gait Training n=19 Participants 1 hour walking exercise on a treadmill Gait training: Walking on a treadmill and receiving verbal cues to improve gait quality
Gait Speed (m/s) Baseline	1.14 m/s Standard Deviation 0.16
Gait Speed (m/s) 2 week	1.21 m/s Standard Deviation 0.16
Gait Speed (m/s) 10 week	1.22 m/s Standard Deviation 0.17
Gait Speed (m/s) 16 week	1.20 m/s Standard Deviation 0.12

PRIMARY outcome

Timeframe: measured at baseline and at 10 weeks

The investigators will use the Montreal Cognitive Assessment (MoCA; score range=0-30, with 30 indicating better cognitive function) as a reflection of global cognitive function

Outcome measures

Measure	Gait Training n=19 Participants 1 hour walking exercise on a treadmill Gait training: Walking on a treadmill and receiving verbal cues to improve gait quality
Montreal Cognitive Assessment Score Baseline	27.1 score on a scale Standard Deviation 1.6
Montreal Cognitive Assessment Score Week 10	27.7 score on a scale Standard Deviation 2.0

Adverse Events

Gait Training

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Gait Training n=19 participants at risk 1 hour walking exercise on a treadmill Gait training: Walking on a treadmill and receiving verbal cues to improve gait quality
General disorders Fall (outside of study visit)	10.5% 2/19 • Number of events 2 • 16 weeks (study duration)
General disorders Lightheadedness	5.3% 1/19 • Number of events 1 • 16 weeks (study duration)
Musculoskeletal and connective tissue disorders Exercise-associated pain, fatigue	15.8% 3/19 • Number of events 3 • 16 weeks (study duration)

Additional Information

Valerie E. Kelly, PT, PhD

University of Washington

Phone: 206-598-5350

Email: vekelly@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place