To Evaluate Effectiveness of the Gait Trainer in Increasing the Functionality and Spatiotemporal Parameters of Gait of 4 Patients.NCT01906723
Evaluation of the Effectiveness of a Novel Gait Trainer in Increasing the Functionality of Motor Impaired Patients: Pilot Study
A study testing Walker in people with To Evaluate Effectiveness of the Gait Trainer in Increasing the Functionality and Spatiotemporal Parameters of Gait of 4 Patients., run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- To Evaluate Effectiveness of the Gait Trainer in Increasing the Functionality and Spatiotemporal Parameters of Gait of 4 Patients.
- What is being tested?
- Walker
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive disorders preventing the subject from understanding the trial protocol or following the researcher's instructions
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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).
- Being tested
- Walker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkerDevice
Also called Up n' Free trainer
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Activity monitor data (via accelerometers)
Measured: 1 week
Secondary outcomes (1)
Spatio-temporal parameters
step length, gait velocity, stance duration
Measured: baseline, 1 week following baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate Effectiveness of the Gait Trainer in Increasing the Functionality and Spatiotemporal Parameters of Gait of 4 Patients.Studies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906723
- Sponsor's protocol ID
- UpnFree-HMO-CTIL
- Status last verified
- Jul 2013
- First submitted
- 21 Jul 2013
- Last updated
- 5 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Novel Gait Trainer in Increasing the Functionality of Motor Impaired Patients: Pilot Study
- ClinicalTrials.gov ID
- NCT01906723
- Acronym / sponsor ID
- UpnFree-HMO-CTIL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Cognitive disorders preventing the subject from understanding the trial protocol or following the researcher's instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WalkerAlso: Up n' Free trainerThe 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. | Device | – |
Primary outcome
Physical activity
Time frame: 1 week
Activity monitor data (via accelerometers)
1 secondary outcome
Spatio-temporal parameters
Time frame: baseline, 1 week following baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walker in people with To Evaluate Effectiveness of the Gait Trainer in Increasing the Functionality and Spatiotemporal Parameters of Gait of 4 Patients., run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.