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Use of Blood Flow Restriction Therapy in Perioperative Rehabilitation Following Achilles Tendon Rupture

Primary Purpose

Achilles Tendon Rupture, Achilles Tendon Surgery

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood flow restriction augmented physical therapy
Physical therapy
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring Blood flow restriction, physical therapy, Achilles tendon, Achilles tendon rupture, Achilles tendon repair

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Henry Ford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blood flow restriction augmented physical therapy

Traditional physical therapy

Arm Description

The group will undergo traditional physical therapy with the augment of blood flow restriction therapy under the supervision of trained physical therapists.

The group will undergo traditional physical therapy without the augment of blood flow restriction therapy under the supervision of trained physical therapists.

Outcomes

Primary Outcome Measures

Change in plantarflexion strength from baseline
Plantarflexion strength to be measured via dynamometer

Secondary Outcome Measures

Change in range of motion
Dorsiflexion and plantar flexion measured with goniometer
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.
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.
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.
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.
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.
Change in calf circumference
Circumference measurements of the calf

Full Information

First Posted
June 7, 2020
Last Updated
January 31, 2023
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04492059
Brief Title
Use of Blood Flow Restriction Therapy in Perioperative Rehabilitation Following Achilles Tendon Rupture
Official Title
Use of Blood Flow Restriction Therapy in Perioperative Rehabilitation Following Achilles Tendon Rupture
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No patients
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
March 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture, Achilles Tendon Surgery
Keywords
Blood flow restriction, physical therapy, Achilles tendon, Achilles tendon rupture, Achilles tendon repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood flow restriction augmented physical therapy
Arm Type
Experimental
Arm Description
The group will undergo traditional physical therapy with the augment of blood flow restriction therapy under the supervision of trained physical therapists.
Arm Title
Traditional physical therapy
Arm Type
Active Comparator
Arm Description
The group will undergo traditional physical therapy without the augment of blood flow restriction therapy under the supervision of trained physical therapists.
Intervention Type
Device
Intervention Name(s)
Blood flow restriction augmented physical therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical therapy
Intervention Description
Completing traditional physical therapy.
Primary Outcome Measure Information:
Title
Change in plantarflexion strength from baseline
Description
Plantarflexion strength to be measured via dynamometer
Time Frame
Measured at six-week, three-month and six-month postoperative visits
Secondary Outcome Measure Information:
Title
Change in range of motion
Description
Dorsiflexion and plantar flexion measured with goniometer
Time Frame
Measured at six-week, three-month and six-month postoperative visits
Title
Achilles Tendon Total Rupture Score
Description
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.
Time Frame
Measured at initial visit, six-week, three-month and six-month postoperative visits
Title
Pain on the visual analog score
Description
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.
Time Frame
Measured at initial visit, six-week, three-month and six-month postoperative visits
Title
PROMIS pain scores
Description
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.
Time Frame
Measured at initial visit, six-week, three-month and six-month postoperative visits
Title
PROMIS function scores
Description
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.
Time Frame
Measured at initial visit, six-week, three-month and six-month postoperative visits
Title
PROMIS depression scores
Description
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.
Time Frame
Measured at initial visit, six-week, three-month and six-month postoperative visits
Title
Change in calf circumference
Description
Circumference measurements of the calf
Time Frame
Measured at initial visit, six-week, three-month and six-month postoperative visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erickson Andrews, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Use of Blood Flow Restriction Therapy in Perioperative Rehabilitation Following Achilles Tendon Rupture

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