Trials / Completed
CompletedNCT01548040
Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement
A Randomised Controlled Study To Compare the Effects of a Standard Therapy Protocol With a 12-week Peri-Operative Program of Kneehab XP Compared to a Control Treatment in Patients Undergoing Total Knee Replacement
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 111 (actual)
- Sponsor
- Theragen Inc. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
The study is a prospective, randomized, double-blind sham study of TKA patients who receive a standard peri-operative treatment program plus Kneehab XP versus a standard peri-operative treatment program plus a sham device.
Detailed description
The study is a double-blind randomized controlled clinical trial of approximately 118 patients (males and females) who are at least 40 years of age, who are scheduled for Total Knee Arthroplasty (TKA) surgery will be randomized into 1) a treatment group who receive Kneehab XP and a standard rehabilitation program and 2) a control group who receive only a sham device and a standard rehabilitation program. Patients are tracked for measures of function, pain, quality of life, physical performance and acceptable states status at 6 weeks and 1 week before surgery and 3, 6, 12, and 52 weeks following surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Kneehab XP | NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively |
| DEVICE | Quadriceps TENS | on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively. |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2016-08-01
- Completion
- 2016-10-01
- First posted
- 2012-03-08
- Last updated
- 2018-04-11
- Results posted
- 2018-03-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01548040. Inclusion in this directory is not an endorsement.