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| Name | Class |
|---|---|
| National University of Singapore | OTHER |
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This is a pilot study that evaluates the effect of PEMF in maintaining muscle mass postoperatively in individuals experiencing clinical immobilisation due ACL reconstruction surgery. Half of the participants will receive the PEMF therapy in combination with standard rehabilitation programme, while the other half will receive sham therapy in combination with standard rehabilitation programme.
This is a single-site, randomized, double-blinded, prospective pilot study of the effectiveness of once-weekly PEMF therapy in the promotion of muscle maintenance following ACL reconstruction surgery. Eligible subjects will be randomized in a 1:1 ratio to receive therapy with an active PEMF device or an identical inactive Sham device, in addition to the standard rehabilitation regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Electromagnetic Field Therapy | Active Comparator | Active Pulsed Electromagnetic Field therapy device; exposed once weekly for 10 minutes. |
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| Sham Therapy | Sham Comparator | Inactive Pulsed Electromagnetic Field therapy device; exposed once weekly for 10 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Electromagnetic Field Therapy | Device | Participants of this arm will be exposed to 10 minutes of Pulsed Electromagnetic Field (PEMF) once a week for a total of 16 weeks. The PEMF device produces pulsed magnetic fields at flux densities up to 1 mT peak. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Volume | % change in muscle volume at the end of 16 weeks compared to baseline | Week 1 and Week 16 post-ACL reconstruction |
| Measure | Description | Time Frame |
|---|---|---|
| Quadriceps strength | Quadricep strength (Ib) measurement by dynamometer | Baseline and Week 8, 12, 16 post-ACL reconstruction |
| Knee and thigh circumference | Measurement of knee girth (cm) from mid portion of the patella and thigh girth (cm) 5 cm above from the superior border of the patella |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lingaraj Krishna, frcs (Orth) | National University Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Health System | Singapore | 119074 | Singapore |
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| Sham Therapy | Device | Participants of this arm will be exposed to 10 minutes of sham therapy once a week for a total of 16 weeks. The Sham device is identical to the PEMF device in physical appearance. |
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| Baseline and Week 1, 4, 8, 12, 16 post-ACL reconstruction |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee Injury and Osteoarthritis Outcome Score (KOOS): a validated knee-specific instrument that measures the short-term and long-term symptoms and function associated with knee injury. KOOS consists of 5 subscales: pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life. | Week 16 post-ACL reconstruction |