Achilles Tendon RuptureNCT04492059
Use of Blood Flow Restriction Therapy in Perioperative Rehabilitation Following Achilles Tendon Rupture
A study testing Blood flow restriction augmented physical therapy and Physical therapy in people with Achilles Tendon Rupture and Achilles Tendon Surgery, run by Henry Ford Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Tendon Rupture, Achilles Tendon Surgery
- What is being tested?
- Blood flow restriction augmented physical therapy and Physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 25 Mar 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18-65 who suffered an achilles tendon rupture.
- Patients with achilles tendon rupture that are being treated operatively and non-operatively.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Following diagnosis of ATR, attending surgeons will discuss treatment options with the patient and determine their course of treatment to be operative or non-operative. Patients will then be randomized via computer to prospectively undergo ATR rehabilitation using conventional therapy or conventional therapy with a BFR adjunct by physical therapists already trained in BFR with extensive experience in ATR rehabilitation. There will be no incentive provided for participation by the therapists and the therapists may opt out of using BFR at any point. Treatment groups will undergo similar protocols with the only difference being the use of BFR as an adjunct to their rehabilitation. The protocol for using the BFR cuff will be similar to previous studies examining BFR in lower extremity injuries, with adaptation to the postoperative protocol specific to the Achilles tendon. More specifically the physical therapists will be provided with a tourniquet that includes a pressure monitor. The skin will be protected with a sleeve and the cuff will be placed in the thigh well proximal to the knee joint. The investigators will begin by determining the patient's limb occlusion pressure, which is conducted automatically by the cuff via built in doppler. Once this is done the cuff will be inflated to 80% of the limb occlusion pressure, which is the currently accepted recommendation in the literature and sufficient to achieve the desired effect of blood flow restriction.
For non-operative candidates the investigators will begin their rehabilitation and physical therapy immediately following their initial office visit. Participants will have follow-up appointments at two-weeks, six-weeks, three-months and six-months. During these follow-up appointments the investigators will assess calf strength, calf circumference, ankle range of motion, current pain and function level. Additionally, the investigators will conduct testing at the end of the therapy sessions to ensure patients are prepared to return to sports.
For operative candidates the investigators will schedule their surgery at the earliest convenience and availability following their initial office visit. Participants will begin their rehabilitation and physical therapy immediately following their surgery. Participants will have follow-up appointments at two-weeks, six-weeks, three-months and six-months. During these follow-up appointments the investigators will assess calf strength, calf circumference, ankle range of motion, current pain and function level. Additionally, the investigators will conduct testing at the end of the therapy sessions to ensure patients are prepared to return to sports.
In both operative and non-operative rehabilitation, therapy will consist of a structured program progressing from range of motion to strength training and then functional tests. Both those randomized to conventional therapy and those randomized to conventional therapy with BFR adjunct will follow the same protocol with the only variable being the use of BFR. Again, the BFR group will have the cuff inflated per protocol outlined above, this will be under the guidance of trained physical therapists.
Throughout this protocol patient will have their initial/pre-operative visit to establish care and set up surgery and follow-up appointments at two-weeks, six-weeks, three-months and six-months. All data collection and testing during these follow-up appointments will be obtained with a handheld device and will add less than five minutes to clinic visits.
- Conditions
- Achilles Tendon Rupture, Achilles Tendon Surgery
- Being tested
- Blood flow restriction augmented physical therapy, Physical therapy
- Keywords
- Blood flow restriction, physical therapy, Achilles tendon, Achilles tendon rupture, Achilles tendon repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction augmented physical therapyDevice
Using a blood flow restriction cuff during physical therapy. It is a pressurized cuff that is used to decrease the amount of oxygen that is available to the muscle during exercise. This stimulates the muscle to believe it is in an anoxic state and can produce greater strength and hypertrophy with fewer reps and less weight which would mean less stress on a surgically repaired tendon.
Physical therapyOther
Completing traditional physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction augmented physical therapy | Experimental | The group will undergo traditional physical therapy with the augment of blood flow restriction therapy under the supervision of trained physical therapists. Receives: Device: Blood flow restriction augmented physical therapy |
| Traditional physical therapy | Active comparator | The group will undergo traditional physical therapy without the augment of blood flow restriction therapy under the supervision of trained physical therapists. Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plantarflexion strength from baseline
Plantarflexion strength to be measured via dynamometer
Measured: Measured at six-week, three-month and six-month postoperative visits
Secondary outcomes (7)
Change in range of motion
Dorsiflexion and plantar flexion measured with goniometer
Measured: Measured at six-week, three-month and six-month postoperative visits
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: Measured at initial visit, six-week, three-month and six-month postoperative visits
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: Measured at initial visit, six-week, three-month and six-month postoperative visits
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: Measured at initial visit, six-week, three-month and six-month postoperative visits
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: Measured at initial visit, six-week, three-month and six-month postoperative visits
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: Measured at initial visit, six-week, three-month and six-month postoperative visits
Change in calf circumference
Circumference measurements of the calf
Measured: Measured at initial visit, six-week, three-month and six-month postoperative visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Sep 2020
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Why it stopped: No patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned to the blood flow restriction augmented physical therapy group following surgery or will undergo the usual physical therapy. Various measurements will be taken at follow up appointments as well as patient reported outcomes and compared between the two groups.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erickson Andrews, M.D., Henry Ford Health System
- Investigators
- Erickson Andrews, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492059
- Sponsor's protocol ID
- BFR Achilles Tendon
- Status last verified
- Jan 2023
- First submitted
- 7 Jun 2020
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heikkinen J, Lantto I, Flinkkila T, Siira P, Laine V, Niinimaki J, Ohtonen P, Leppilahti J.
Wernbom M, Augustsson J, Raastad T. Ischemic strength training: a low-load alternative to heavy resistance exercise? Scand J Med Sci Sports. 2008 Aug;18(4):401-16. doi: 10.1111/j.1600-0838.2008.00788.x. Epub 2008 May 3.
PubMed 18466185Centner C, Lauber B, Seynnes OR, Jerger S, Sohnius T, Gollhofer A, Konig D. Low-load blood flow restriction training induces similar morphological and mechanical Achilles tendon adaptations compared with high-load resistance training. J Appl Physiol (1985). 2019 Dec 1;127(6):1660-1667. doi: 10.1152/japplphysiol.00602.2019. Epub 2019 Nov 14.
PubMed 31725362Yow BG, Tennent DJ, Dowd TC, Loenneke JP, Owens JG. Blood Flow Restriction Training After Achilles Tendon Rupture. J Foot Ankle Surg. 2018 May-Jun;57(3):635-638. doi: 10.1053/j.jfas.2017.11.008. Epub 2018 Feb 21.
PubMed 29477554Ladlow P, Coppack RJ, Dharm-Datta S, Conway D, Sellon E, Patterson SD, Bennett AN. Low-Load Resistance Training With Blood Flow Restriction Improves Clinical Outcomes in Musculoskeletal Rehabilitation: A Single-Blind Randomized Controlled Trial. Front Physiol. 2018 Sep 10;9:1269. doi: 10.3389/fphys.2018.01269. eCollection 2018.
PubMed 30246795DePhillipo NN, Kennedy MI, Aman ZS, Bernhardson AS, O'Brien L, LaPrade RF. Blood Flow Restriction Therapy After Knee Surgery: Indications, Safety Considerations, and Postoperative Protocol. Arthrosc Tech. 2018 Sep 24;7(10):e1037-e1043. doi: 10.1016/j.eats.2018.06.010. eCollection 2018 Oct.
PubMed 30377584Noordin S, McEwen JA, Kragh JF Jr, Eisen A, Masri BA. Surgical tourniquets in orthopaedics. J Bone Joint Surg Am. 2009 Dec;91(12):2958-67. doi: 10.2106/JBJS.I.00634.
PubMed 19952261Clark BC, Manini TM, Hoffman RL, Williams PS, Guiler MK, Knutson MJ, McGlynn ML, Kushnick MR. Relative safety of 4 weeks of blood flow-restricted resistance exercise in young, healthy adults. Scand J Med Sci Sports. 2011 Oct;21(5):653-62. doi: 10.1111/j.1600-0838.2010.01100.x. Epub 2010 Mar 11.
PubMed 21917016Madarame H, Sasaki K, Ishii N. Endocrine responses to upper- and lower-limb resistance exercises with blood flow restriction. Acta Physiol Hung. 2010 Jun;97(2):192-200. doi: 10.1556/APhysiol.97.2010.2.5.
PubMed 20511128
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Blood Flow Restriction Therapy in Perioperative Rehabilitation Following Achilles Tendon Rupture
- ClinicalTrials.gov ID
- NCT04492059
- Acronym / sponsor ID
- BFR Achilles Tendon
- Conditions
- Achilles Tendon Rupture, Achilles Tendon Surgery
- Keywords
- Blood flow restriction, physical therapy, Achilles tendon, Achilles tendon rupture, Achilles tendon repair
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 30 Jul 2020 (actual)
- 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.
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.
Detailed description
Following diagnosis of ATR, attending surgeons will discuss treatment options with the patient and determine their course of treatment to be operative or non-operative. Patients will then be randomized via computer to prospectively undergo ATR rehabilitation using conventional therapy or conventional therapy with a BFR adjunct by physical therapists already trained in BFR with extensive experience in ATR rehabilitation. There will be no incentive provided for participation by the therapists and the therapists may opt out of using BFR at any point. Treatment groups will undergo similar protocols with the only difference being the use of BFR as an adjunct to their rehabilitation. The protocol for using the BFR cuff will be similar to previous studies examining BFR in lower extremity injuries, with adaptation to the postoperative protocol specific to the Achilles tendon. More specifically the physical therapists will be provided with a tourniquet that includes a pressure monitor. The skin will be protected with a sleeve and the cuff will be placed in the thigh well proximal to the knee joint. The investigators will begin by determining the patient's limb occlusion pressure, which is conducted automatically by the cuff via built in doppler. Once this is done the cuff will be inflated to 80% of the limb occlusion pressure, which is the currently accepted recommendation in the literature and sufficient to achieve the desired effect of blood flow restriction.
For non-operative candidates the investigators will begin their rehabilitation and physical therapy immediately following their initial office visit. Participants will have follow-up appointments at two-weeks, six-weeks, three-months and six-months. During these follow-up appointments the investigators will assess calf strength, calf circumference, ankle range of motion, current pain and function level. Additionally, the investigators will conduct testing at the end of the therapy sessions to ensure patients are prepared to return to sports.
For operative candidates the investigators will schedule their surgery at the earliest convenience and availability following their initial office visit. Participants will begin their rehabilitation and physical therapy immediately following their surgery. Participants will have follow-up appointments at two-weeks, six-weeks, three-months and six-months. During these follow-up appointments the investigators will assess calf strength, calf circumference, ankle range of motion, current pain and function level. Additionally, the investigators will conduct testing at the end of the therapy sessions to ensure patients are prepared to return to sports.
In both operative and non-operative rehabilitation, therapy will consist of a structured program progressing from range of motion to strength training and then functional tests. Both those randomized to conventional therapy and those randomized to conventional therapy with BFR adjunct will follow the same protocol with the only variable being the use of BFR. Again, the BFR group will have the cuff inflated per protocol outlined above, this will be under the guidance of trained physical therapists.
Throughout this protocol patient will have their initial/pre-operative visit to establish care and set up surgery and follow-up appointments at two-weeks, six-weeks, three-months and six-months. All data collection and testing during these follow-up appointments will be obtained with a handheld device and will add less than five minutes to clinic visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be assigned to the blood flow restriction augmented physical therapy group following surgery or will undergo the usual physical therapy. Various measurements will be taken at follow up appointments as well as patient reported outcomes and compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction augmented physical therapy | Experimental | Device: Blood flow restriction augmented physical therapyThe group will undergo traditional physical therapy with the augment of blood flow restriction therapy under the supervision of trained physical therapists. |
| Traditional physical therapy | Active comparator | Other: Physical therapyThe group will undergo traditional physical therapy without the augment of blood flow restriction therapy under the supervision of trained physical therapists. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 18-65 who suffered an achilles tendon rupture.
- Patients with achilles tendon rupture that are being treated operatively and non-operatively.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Blood flow restriction augmented physical therapyUsing a blood flow restriction cuff during physical therapy. It is a pressurized cuff that is used to decrease the amount of oxygen that is available to the muscle during exercise. This stimulates the muscle to believe it is in an anoxic state and can produce greater strength and hypertrophy with fewer reps and less weight which would mean less stress on a surgically repaired tendon. | Device | Blood flow restriction augmented physical therapy |
| Physical therapyCompleting traditional physical therapy. | Other | Traditional physical therapy |
Primary outcome
Change in plantarflexion strength from baseline
Time frame: Measured at six-week, three-month and six-month postoperative visits
Plantarflexion strength to be measured via dynamometer
7 secondary outcomes
Change in range of motion
Time frame: Measured at six-week, three-month and six-month postoperative visits
Achilles Tendon Total Rupture Score
Time frame: Measured at initial visit, six-week, three-month and six-month postoperative visits
Pain on the visual analog score
Time frame: Measured at initial visit, six-week, three-month and six-month postoperative visits
PROMIS pain scores
Time frame: Measured at initial visit, six-week, three-month and six-month postoperative visits
PROMIS function scores
Time frame: Measured at initial visit, six-week, three-month and six-month postoperative visits
PROMIS depression scores
Time frame: Measured at initial visit, six-week, three-month and six-month postoperative visits
Change in calf circumference
Time frame: Measured at initial visit, six-week, three-month and six-month postoperative visits
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- BackgroundHeikkinen J, Lantto I, Flinkkila T, Siira P, Laine V, Niinimaki J, Ohtonen P, Leppilahti J.
- Background: PubMed 18466185Wernbom M, Augustsson J, Raastad T. Ischemic strength training: a low-load alternative to heavy resistance exercise? Scand J Med Sci Sports. 2008 Aug;18(4):401-16. doi: 10.1111/j.1600-0838.2008.00788.x. Epub 2008 May 3.
- Background: PubMed 31725362Centner C, Lauber B, Seynnes OR, Jerger S, Sohnius T, Gollhofer A, Konig D. Low-load blood flow restriction training induces similar morphological and mechanical Achilles tendon adaptations compared with high-load resistance training. J Appl Physiol (1985). 2019 Dec 1;127(6):1660-1667. doi: 10.1152/japplphysiol.00602.2019. Epub 2019 Nov 14.
- Background: PubMed 29477554Yow BG, Tennent DJ, Dowd TC, Loenneke JP, Owens JG. Blood Flow Restriction Training After Achilles Tendon Rupture. J Foot Ankle Surg. 2018 May-Jun;57(3):635-638. doi: 10.1053/j.jfas.2017.11.008. Epub 2018 Feb 21.
- Background: PubMed 30246795Ladlow P, Coppack RJ, Dharm-Datta S, Conway D, Sellon E, Patterson SD, Bennett AN. Low-Load Resistance Training With Blood Flow Restriction Improves Clinical Outcomes in Musculoskeletal Rehabilitation: A Single-Blind Randomized Controlled Trial. Front Physiol. 2018 Sep 10;9:1269. doi: 10.3389/fphys.2018.01269. eCollection 2018.
- Background: PubMed 30377584DePhillipo NN, Kennedy MI, Aman ZS, Bernhardson AS, O'Brien L, LaPrade RF. Blood Flow Restriction Therapy After Knee Surgery: Indications, Safety Considerations, and Postoperative Protocol. Arthrosc Tech. 2018 Sep 24;7(10):e1037-e1043. doi: 10.1016/j.eats.2018.06.010. eCollection 2018 Oct.
- Background: PubMed 19952261Noordin S, McEwen JA, Kragh JF Jr, Eisen A, Masri BA. Surgical tourniquets in orthopaedics. J Bone Joint Surg Am. 2009 Dec;91(12):2958-67. doi: 10.2106/JBJS.I.00634.
- Background: PubMed 21917016Clark BC, Manini TM, Hoffman RL, Williams PS, Guiler MK, Knutson MJ, McGlynn ML, Kushnick MR. Relative safety of 4 weeks of blood flow-restricted resistance exercise in young, healthy adults. Scand J Med Sci Sports. 2011 Oct;21(5):653-62. doi: 10.1111/j.1600-0838.2010.01100.x. Epub 2010 Mar 11.
- Background: PubMed 20511128Madarame H, Sasaki K, Ishii N. Endocrine responses to upper- and lower-limb resistance exercises with blood flow restriction. Acta Physiol Hung. 2010 Jun;97(2):192-200. doi: 10.1556/APhysiol.97.2010.2.5.
- Individual participant dataSharing planned: No
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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.
Erickson Andrews, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction augmented physical therapy and Physical therapy in people with Achilles Tendon Rupture and Achilles Tendon Surgery, run by Henry Ford Health System at 1 site in United States.
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 2 inclusion and 8 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: withdrawn, as of the sponsor's last update on 2 Feb 2023. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in plantarflexion strength from baseline (time frame: Measured at six-week, three-month and six-month postoperative visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04492059, which also lists 9 linked publications.
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 2 Feb 2023.