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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03558100
Other study ID # 3820E
Secondary ID R03AR066344-01A1
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2014
Est. completion date July 15, 2019

Study information

Verified date July 2019
Source Boston University Charles River Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the clinical study was to examine if practice could improve walking patterns associated with fall risks before patients with obesity underwent weight loss surgery. We hypothesized that patients would show improvements in their walking after completing the intervention. For the intervention, patients walked under five conditions: on flat ground at the beginning of the study, crossing three obstacle heights, and on flat ground at the end of the study for a total of 25 times.


Description:

Obesity has a negative impact on aspects of walking associated with fall risks. After weight loss surgery, adults show improvements in walking. However, those who undergo surgery still show deficits in walking and an additional group of individuals do not undergo the procedure. Our objective was to examine if practice could improve gait patterns associated with fall risks before patients underwent weight loss surgery. Adults with obese body mass index between 30 to 60 years old who were eligible to undergo the Roux-en-Y weight loss surgery procedure walked under five conditions: initial baseline walking on flat ground, crossing three obstacle heights, and final baseline walking on flat ground for a total of 25 trials. Spatio-temporal gait parameters were collected using a gait carpet and body-worn sensors. The GAITRite mat was a 4.9 m long x 0.6 m wide pressure-sensitive mat with a temporal resolution of 120 Hz and a spatial resolution of 1.3 cm. LEGSysTM includes five wearable sensors containing triaxial gyroscopes, accelerometers, and magnetometers. Dependent variables selected included velocity (cm/s), cadence (steps/minute), step length (distance between consecutive steps), step width (lateral distance between feet), single limb support time (amount of time spent on one leg during the walking cycle), and double limb support time (amount of time spend on two legs during the walking cycle).


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date July 15, 2019
Est. primary completion date July 15, 2019
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria:

- between 30 and 60 years old

- eligible to undergo Roux-en-Y gastric bypass surgery

- walk independently without assistive devices

Exclusion Criteria:

- scheduled to undergo knee surgery

- receiving dialysis

- being treated for cancer

Study Design


Intervention

Behavioral:
Obstacle crossing intervention for adults with obesity
The obstacle crossing intervention will be done for reducing falls risks in obesity. The intervention will provide gait practice to individuals with obesity who are eligible for and prior to weight loss surgery.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Boston University Charles River Campus National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

References & Publications (1)

Gill SV, Walsh MK, Pratt JA, Toosizadeh N, Najafi B, Travison TG. Changes in spatiotemporal gait patterns during flat ground walking and obstacle crossing 1 year after bariatric surgery. Surg Obes Relat Dis. 2016 Jun;12(5):1080-1085. doi: 10.1016/j.soard. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Velocity (cm/s) walking speed The change from baseline velocity (cm/s) at 12 months
Secondary Cadence (steps per minute) steps per minute The change from baseline cadence (steps per minute) at 12 months
Secondary Step width (cm) lateral distance between feet The change from baseline step width (cm) at 12 months
Secondary single limb support time (msec) time spent balancing on one leg The change from baseline single limb support time (msec) at 12 months
Secondary double limb support time (msec) time spent balancing on both legs The change from baseline double limb support time (msec) at 12 months
Secondary step length (cm) distance between consecutive steps The change from baseline step length (cm) at 12 months
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