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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906723
• Other study ID #: UpnFree-HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: July 21, 2013
• Last updated: January 4, 2016
• Start date: August 2013

Study information

• Verified date: July 2013
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ministry of Health - Director General:Israel
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Device:
• Walker
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.

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	Activity monitor data (via accelerometers)	1 week	No
Secondary	Spatio-temporal parameters	step length, gait velocity, stance duration	baseline, 1 week following baseline	No