Evaluation of the Effectiveness of a Novel Gait Trainer in Increasing the Functionality of Motor Impaired Patients: Pilot Study
Condition: To Evaluate Effectiveness of the Gait Trainer in Increasing the Functionality and Spatiotemporal Parameters of Gait of 4 Patients.
Study type: Interventional

Summary: 
      Unstrained ambulation is the main goal of gait rehabilitation for preventing fatigue and
      increasing functionality in patients with gait deficiencies. The Up n' Free (Easy Walking) is
      a gait trainer equipped with a dynamic partial weight-bearing. The trainer is designed to
      provide the user with independence, safety, and endurance. It allows for easy transfer from
      sitting to standing position and stabilizes the pelvis, allowing for free movement of the
      hands. The effectiveness of the Up n' Free trainer in increasing the patient's functionality
      at the hospital or at home has not been quantified. We therefore aim to evaluate
      effectiveness of the gait trainer in increasing the functionality and spatiotemporal
      parameters of gait of 4 patients.
    

Detailed description: 
      Four ambulatory adults with postpolio syndrome, multiple sclerosis, cerebral palsy and spinal
      cord injury will be recruited for the study (one of each pathology).

      Inclusion criteria:

        -  Ambulatory patients ages of 18 and above

        -  Cognitive and cooperative ability to follow simple instructions

        -  Independently capable to understand an informed consent form

        -  Weight below 100kg

      Exclusion criteria:

      • Cognitive disorders preventing the subject from understanding the trial protocol or
      following the researcher's instructions

      2.2 Trial Protocol The subjects will be recruited from the rehabilitation department at the
      Hadassah medical center. Each subject will understand and agree to an informed consent form
      pretrial. The subjects' age, weight, and BMI will be documented. They will then receive a 10-
      minutes instruction on using the Up n' Free gait trainer and will be provided with the
      trainer for the 1-week duration of the trial. Spatiotemporal parameters and gait symmetry
      will be recorded in the Hadassah gait laboratory, while the patient ambulates with his or her
      own walking aid. Physical Activity (PA) will be assessed using triaxial accelerometer-based
      activity monitors (ActiGraph GT3X, Pensacola, Florida, USA), using a preset sampling epoch of
      1s. The participants will be instructed to wear the activity monitors on their right hip for
      7 consecutive days and only remove it during night time sleep or water activities. At the end
      of 7 days the subjects will return the Up n' Free gait trainer and fill out a satisfactory
      questionnaire. Spatiotemporal parameters and gait symmetry will be recorded again in the
      Hadassah gait laboratory, while the patient ambulates with the Up n' Free.

      2.3 Data Analysis Estimates of the PA will be weighed by 5/7th of the weekly activity for the
      weekdays (Sunday-Thursday) and 2/7th for weekend days (Friday and Saturday) as within-week
      variation is expected. Total PA (1,000 counts × day-1), wear time PA (count × min-1),
      sedentary time (hours × day-1; between 0-99 counts/min), low-light PA (min×day-1; between
      100-759 counts/min), High-light PA (min × day-1; 760-2019 counts/min), moderate-vigorous PA
      (min × day-1; ≥2020 counts/min).
    

Intervention name(s): Walker
Intervention type(s): Device
Intervention description(s): The Up n' Free (Easy Walking) is a gait trainer equipped with a dynamic partial weight-bearing. The trainer is designed to provide the user with independence, safety, and endurance. It allows for easy transfer from sitting to standing position and stabilizes the pelvis, allowing for free movement of the hands.
Other intervention name(s): Up n' Free trainer
Primary purpose: Supportive Care