Improved Recovery of Walking in Acquired Muscle Weakness

The scale measures six bilateral muscle groups (wrist flexion, elbow flexion, shoulder abduction, ankle dorsiflexion, knee extension and hip flexion) with a maximum score of 60 points (normality) and a minimum score of 0 points (No muscle contraction visible or palpable).

Walking speed is measured by the timed 10-meter Walk Test (10MWT). Participants walk a distance of 10 meters at their usual speed with their usual walking aids. Participants are timed while walking 10 meters from a starting point to an end point. Time taken from meter 2 to meter 8. Two repetitions are completed and the average time is used to calculate walking speed in metres/second. During the test, EMG and kinematic data will be recorded using EMG-sensors and three IMUs, two placed on the feet and one on the lower back.

Measurement instrument, based on an ordinal scale, commonly used to assess daily life activities. The total score ranges from 0 (total dependency) to 100 (full autonomy).

Walking capacity is measured with the Participant timed while walking a 30 meter track constantly for 6 minutes. Participants are permitted to use their walking aids if necessary, and Patients will wear an IMU. The distance walked in 6 minutes is recorded and reported in meters.

The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk. Patient are timed while standing up from a chair walking 3 meters, turning around, walking 3 meters and sitting down again.

The patient sits in the chair with his/her back against the chair back. On the command "go," the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down.

Timing begins at the instruction "go" and stops when the patient is seated.

EQ-5D-5L is a standardized instrument for use as a measure of health for clinical and economic appraisal.Applicable to a wide range of health conditions and treatments, the EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.

Measures the 5 dimensions of:

mobility self-care usual activities pain/discomfort anxiety/depression Each dimension is scored on a Likert scale of 5 levels, with higher scores indicating more severe problems.

It measures the degree of satisfaction of the subject in terms of improvement of the treatment received. The total score ranges from 0 (not satisfied) to 40(full satisfied).

Needle Electromyography (EMG) will be used for both qualitative and quantitative analysis of muscle activity.

Collected data:

• Spontaneous activity: Analysis of fibrillation potentials and positive sharp waves in target muscles of the upper and lower limbs.
• Voluntary activity: Analysis of motor unit potential recruitment patterns and amplitude in target muscles of the upper and lower limbs.

Electroneurography (ENG) data will be collected separately for motor and sensory nerve conduction studies. Direct muscle stimulation will be performed to differentiate predominantly neuropathic from predominantly myopathic forms. Collected data will be:

• Amplitude of Compound Muscle Action Potential (CMAP) (measured in millivolts [mV]).
• Amplitude of Sensory Nerve Action Potential (SNAP) (measured in millivolts [mV]).

Electroneurography (ENG) data will be collected separately for motor and sensory nerve conduction studies. Direct muscle stimulation will be performed to differentiate predominantly neuropathic from predominantly myopathic forms. Collected data will be:

• Latency of CMAP (measured in milliseconds [ms]).
• Latency of SNAP (measured in milliseconds [ms]).
• Duration of CMAP(measured in milliseconds [ms]).
• Duration of SNAP (measured in milliseconds [ms]).
• F-response latency of major nerve trunks (measured in milliseconds [ms]).

Postural data of the lower limb will be acquired using an optoelectronic system combined with two force plates, sampling at 2000 Hz. Utilizing data processing techniques, deviations from normal postural dynamics will be determined.

Falls diaries gather information about the frequency of falls and the circumstances in which the fall occurred. The information include: date/time of fall; location of fall; what caused the fall; type of injury sustained; action taken.

Organized reporting of adverse events occurring during the use of the device

Gender of enrolled subject

Age of enrolled subject

Scholarity of enrolled subject