Trial Outcomes & Findings for Amplitude and Rate of Intrinsic Feedback During Treadmill Training for Parkinson's Disease (NCT NCT01987557)

Results Overview

A measure of the motor symptom severity within Parkinsons. UPDRS III is a qualitative assessment performed by a trained clinician. Specifically, a change in UPDRS III from pre to post is the main outcome measure. The UPDRS-III score is a summation of 27 tasks that are scored from 0-4. 0 meaning no impairment, and 4 representing extreme impairment, inability to complete task. Possible scores on the UPDRS-III range from 0 (no impairment) to 108 (extreme impairment).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

Pre assessments are conducted in the week prior to the treadmill program. Post are conducted during the week immediately following the program. Changes after the 6 week treadmill program are being examined

Results posted on

2015-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	Treadmill Intervention 1: Rate Group Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace. rate group: walking with a high cadence (steps per minute)	Magnitude Treadmill Group In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs magnitude treadmill group	Regular Treadmill Walking participants will walk at a comfortable self-selected pace on a treadmill regular treadmill walking
Overall Study STARTED	16	16	16
Overall Study COMPLETED	13	13	13
Overall Study NOT COMPLETED	3	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Treadmill Intervention 1: Rate Group Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace. rate group: walking with a high cadence (steps per minute)	Magnitude Treadmill Group In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs magnitude treadmill group	Regular Treadmill Walking participants will walk at a comfortable self-selected pace on a treadmill regular treadmill walking
Overall Study Protocol Violation	1	0	1
Overall Study Withdrawal by Subject	2	1	2
Overall Study Adverse Event	0	2	0

Baseline Characteristics

Amplitude and Rate of Intrinsic Feedback During Treadmill Training for Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treadmill Intervention 1: Rate Group n=13 Participants Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace. rate group: walking with a high cadence (steps per minute)	Magnitude Treadmill Group n=13 Participants In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs magnitude treadmill group	Regular Treadmill Walking n=13 Participants participants will walk at a comfortable self-selected pace on a treadmill regular treadmill walking	Total n=39 Participants Total of all reporting groups
Age, Continuous	63.77 years STANDARD_DEVIATION 7.01 • n=5 Participants	70.46 years STANDARD_DEVIATION 9.52 • n=7 Participants	66.31 years STANDARD_DEVIATION 9.07 • n=5 Participants	66.85 years STANDARD_DEVIATION 8.83 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	34 Participants n=4 Participants
Unified Parkinsons Disease Rating Scale-Motor Subsection (UPDRS III)	23.35 units on a scale STANDARD_DEVIATION 8.13 • n=5 Participants	22.96 units on a scale STANDARD_DEVIATION 6.93 • n=7 Participants	22.46 units on a scale STANDARD_DEVIATION 8.64 • n=5 Participants	22.92 units on a scale STANDARD_DEVIATION 7.73 • n=4 Participants

PRIMARY outcome

Timeframe: Pre assessments are conducted in the week prior to the treadmill program. Post are conducted during the week immediately following the program. Changes after the 6 week treadmill program are being examined

A measure of the motor symptom severity within Parkinsons. UPDRS III is a qualitative assessment performed by a trained clinician. Specifically, a change in UPDRS III from pre to post is the main outcome measure. The UPDRS-III score is a summation of 27 tasks that are scored from 0-4. 0 meaning no impairment, and 4 representing extreme impairment, inability to complete task. Possible scores on the UPDRS-III range from 0 (no impairment) to 108 (extreme impairment).

Outcome measures

Outcome measures
Measure	Treadmill Intervention 1: Rate Group n=13 Participants Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace. rate group: walking with a high cadence (steps per minute)	Magnitude Treadmill Group n=13 Participants In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs magnitude treadmill group	Regular Treadmill Walking n=13 Participants participants will walk at a comfortable self-selected pace on a treadmill regular treadmill walking
Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III) PRE	23.35 units on a scale (0-4) Standard Deviation 8.13	22.96 units on a scale (0-4) Standard Deviation 6.93	22.46 units on a scale (0-4) Standard Deviation 8.64
Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III) POST	18.81 units on a scale (0-4) Standard Deviation 7.17	20.69 units on a scale (0-4) Standard Deviation 8.39	20.92 units on a scale (0-4) Standard Deviation 6.14

SECONDARY outcome

Timeframe: pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.

Participants will walk on a pressure sensitive GAITRite carpet (Sparta, NJ), at both comfortable and fast paced walking speeds. Changes in gait characteristics from pre to post are what is being examined. Quantitative measures of gait such as step time, step length, walking velocity, and others will be used in the analysis. Spotters are always present to ensure safety during this assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.

A Balance SD system from BIODEX (Shirley, NY) will be used to assess postural control. Changes from pre to post are what is being examined.

Outcome measures

Outcome data not reported

Adverse Events

Treadmill Intervention 1: Rate Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Magnitude Treadmill Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Regular Treadmill Walking

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treadmill Intervention 1: Rate Group n=16 participants at risk Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace. rate group: walking with a high cadence (steps per minute)	Magnitude Treadmill Group n=16 participants at risk In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs magnitude treadmill group	Regular Treadmill Walking n=16 participants at risk participants will walk at a comfortable self-selected pace on a treadmill regular treadmill walking
Musculoskeletal and connective tissue disorders Muscle Strain	0.00% 0/16	6.2% 1/16 • Number of events 1	0.00% 0/16
Musculoskeletal and connective tissue disorders back muscle tightness	0.00% 0/16	6.2% 1/16 • Number of events 1	0.00% 0/16

Additional Information

Matthew Lasswell

WilfridLU

Phone: 9056992087

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place