An interventional study of Walker in To Evaluate Effectiveness of the Gait Trainer in Increasing the Functionality and Spatiotemporal Parameters of Gait of 4 Patients., sponsored by Hadassah Medical Organization. Completed at 1 site in Israel. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-01-05.
Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Supportive care
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.
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:
Exclusion criteria:
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).
Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
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.
Also known as: Up n' Free trainer
Physical activity
Activity monitor data (via accelerometers)
Time frame: 1 week
Spatio-temporal parameters
step length, gait velocity, stance duration
Time frame: baseline, 1 week following baseline
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Hadassah Medical Organization