Completed

NCT Number: NCT01906723

Evaluation of the Effectiveness of a Novel Gait Trainer in Increasing the Functionality of Motor Impaired Patients: Pilot Study

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.

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Key information

Conditions

To Evaluate Effectiveness of the Gait Trainer in Increasing the Functionality and Spatiotemporal Parameters of Gait of 4 Patients.

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Center

Jerusalem, Israel

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walker

Device

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 names: Up n' Free trainer

Primary outcomes

Physical activity

Time frame: 1 week

Activity monitor data (via accelerometers)

Secondary outcomes

Spatio-temporal parameters

Time frame: baseline, 1 week following baseline

step length, gait velocity, stance duration

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2014
First posted: Jul 24, 2013
Registry last updated: Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.