- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01906723
Evaluation of the Effectiveness of a Novel Gait Trainer in Increasing the Functionality of Motor Impaired Patients: Pilot Study
Study Overview
Status
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Jerusalem, Israel
- Hadassah Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity
Time Frame: 1 week
|
Activity monitor data (via accelerometers)
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spatio-temporal parameters
Time Frame: baseline, 1 week following baseline
|
step length, gait velocity, stance duration
|
baseline, 1 week following baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UpnFree-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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