Achilles Tendon Rupture Clinical Trial
Official title:
Use of Blood Flow Restriction Therapy in Perioperative Rehabilitation Following Achilles Tendon Rupture
Verified date | January 2023 |
Source | Henry Ford Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy in the rehabilitation of Achilles tendon rupture (ATR). Muscle atrophy occurs following Achilles tendon rupture, whether managed non operatively or operatively, which has implications on patient outcomes. The goal of physical therapy in the perioperative period is to regain and ultimately return to activity. BFR has been proposed to reduce atrophy and maintain strength, which would theoretically mitigate the deconditioning effects of an injury on surrounding musculature. BFR is proposed to work by restricting arterial inflow leading to an oxygen depleted environment and the ability to induce muscle adaption at lower maximum repetition via reactive hyperemia and induction of growth cytokines, thus leading to muscle hypertrophy. The goal of this investigation is to determine if using BFR as an adjunct in physical therapy following ATR would reduce muscular atrophy and lead to increased and expedited strength gains. Additionally, the investigators would like to determine if BFR accelerates the rehabilitation process and allows patients to perform standard rehabilitative functional tests and return to play sooner. Furthermore, the investigators will investigate patient reported outcomes metrics. The investigators hypothesize that the BFR group will have significantly greater strength gains at all time points in both non operatively and operatively treated ATR. Previous studies have shown that BFR has potential in increasing Achilles tendon stiffness, tendon cross-sectional area, muscle strength and muscle hypertrophy. However, there is a lack of evidence regarding the use of BFR in both the pre and postoperative period specifically relating to ATR. The investigators believe that the use of BFR in the perioperative period surrounding an Achilles tendon rupture and ATR has the potential to significantly decreased muscle atrophy, improve patient satisfaction and lead to earlier return to sport.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 25, 2022 |
Est. primary completion date | March 25, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - patients aged 18-65 who suffered an achilles tendon rupture. - Patients with achilles tendon rupture that are being treated operatively and non-operatively. Exclusion Criteria: - undergoing a revision procedure - other concomitant injuries of the same leg - have a history of deep vein thrombosis - peripheral vascular disease - neurovascular injury to the extremity - are unable to tolerate BFR treatment - have a leg circumference greater than the largest available tourniquet circumference of 96.52 cm - unable to complete physical therapy. |
Country | Name | City | State |
---|---|---|---|
United States | Henry Ford Hospital | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Henry Ford Health System |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in plantarflexion strength from baseline | Plantarflexion strength to be measured via dynamometer | Measured at six-week, three-month and six-month postoperative visits | |
Secondary | Change in range of motion | Dorsiflexion and plantar flexion measured with goniometer | Measured at six-week, three-month and six-month postoperative visits | |
Secondary | Achilles Tendon Total Rupture Score | Score used to assess disability and function of patients with achilles tendon rupture. Range is 0-100, with 100 being full function and no deficits. | Measured at initial visit, six-week, three-month and six-month postoperative visits | |
Secondary | Pain on the visual analog score | Patient self assessment of current pain. Range is 0 - 10, with 0 being no pain and 10 being the worst pain the patient has experienced. | Measured at initial visit, six-week, three-month and six-month postoperative visits | |
Secondary | PROMIS pain scores | Patient reported outcomes using the PROMIS algorithm. 50 is average, the standard deviation is 10. Range is 0-100. A score of 60 would indicate one standard deviation more pain than average. | Measured at initial visit, six-week, three-month and six-month postoperative visits | |
Secondary | PROMIS function scores | Patient reported outcomes using the PROMIS algorithm. 50 is average, the standard deviation is 10. Range is 0-100. A score of 60 would indicate one standard deviation better function than the average. | Measured at initial visit, six-week, three-month and six-month postoperative visits | |
Secondary | PROMIS depression scores | Patient reported outcomes using the PROMIS algorithm. 50 is average, standard deviation is 10. Range is 0-100. A score of 60 would indicated one standard deviation more depression than average. | Measured at initial visit, six-week, three-month and six-month postoperative visits | |
Secondary | Change in calf circumference | Circumference measurements of the calf | Measured at initial visit, six-week, three-month and six-month postoperative visits |
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