Short-Term Effect Of Ceriter Stride One (CSO) on FOG and Falling in pwP

There is scientific evidence for making pwP stop at the onset of propulsion (when step length decreases and step frequency increases) in order to get the COG back within the base of support. Similarly, (auditory) cues are recommended to facilitate starting.

These principles are implemented with the CSO : the device makes the pmP stop at onset of propulsion and generates an auditory, rhythmic cue to facilitate starting and walking with larger steps (prevention).

This is an innovative application, not a standard-of-care intervention.

Protocol :

20 persons with Parkinson's disease (H&Y 4) (attending physical therapy at Movita).

The test proceeds in 3 stages : preparation / gait test / subjective evaluation :

Preparation

• Info / IC
• General data : age, sex, number of years since diagnosis, use of aids, medication, fall incidents last week (fall diary based on fall diary), (last intake) medication and current efficacy (VAS).
• MDS-UPDRS-II (degree of dependence), nFOGQ, Montreal Cognitive Assessment (MOCA).

Clinical gait test :

The soles are placed in the patient's shoes. If the patient uses an assistive device in daily life, the test is performed with an assistive device.

Following procedure is done in a randomized order*:

• Walking without auditory cue: for 3 minutes, the patient is asked to walk back and forth at a comfortable pace on a 4-meter course through a doorway (start : 2 meters before the doorway, stop : 2 meters beyond the doorway) without any auditory support. If no freezing occurs during this period, pwP is asked to turn 360° in the doorway.

The first 1.5 minutes gait is performed without a double task, the next 1.5 minutes with a cognitive double task (100 - 3 = ... - 3 = ... -3 = ...).

• Walking with auditory cues: for 3 minutes the patient is asked to walk back and forth at a comfortable pace along a 4-meter course through a doorway (start : 2 meters in front of the doorway, stop : 2 meters beyond the doorway) with auditory cues given at the occurrence of a freeze. If no FOG occured, the pwP is asked to turn 360° in the doorway.

The first 1.5 minutes gait is performed without a dual task, the next 1.5 minutes with a cognitive dual task (100 - 3 = ... - 3 = ... -3 = ...).

After each condition (with - without auditory cueing) a short break (2 minutes) is taken, during which a Borg scale for fatigue is taken. After the second condition, satisfaction with the effect of the aid is questioned (see below).

The entire gait test is filmed (by a 2nd person). In this way data, including the number of freezing episodes, can be checked.

*Randomization of conditions: per 2 patients. The first patient draws a card indicating whether or not the patient starts with auditory cues while walking. The 2nd patient then starts with the other condition, and so on. Thus we obtain 10 patients starting with the auditory cueing condition and 10 without.

Parameters considered : duration/step, gait asymmetry (pressure of left foot vs. right foot), number of freezing periods, distance walked, number of steps, mean step length.

Satisfaction questions

• On a scale of 1 to 10, how would you rate the level of comfort of the Ceriter Stride One?
• On a scale of 1 to 10, how safe do you feel when using the Ceriter Stride One?
• To what extent do you feel more secure, on a scale of 1 to 10, while walking by using the Ceriter Stride One?
• Open question : do you have any comments, concerns or questions of your own?

Inclusion criteria

Parkinson's disease (or other Parkinsonism)

• gait impairment with freezing of gait (FOG)
• 18-80 years old
• I.C. (informed consent)
• Montreal Cognitive Assessment (MoCA) >25

Exclusion criteria

• unable to walk 4m without assistance
• MoCA < 25
• no FOG