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A Study to Compare Two Rehabilitation Protocols for Knee Osteoarthritis

E

Ente Ospedaliero Cantonale, Bellinzona

Status

Enrolling

Conditions

Knee Osteoarthritis

Treatments

Other: Anti-gravity treadmill
Other: Blood flow restriction training + Anti-gravity treadmill

Study type

Interventional

Funder types

Other

Identifiers

NCT05728827
ORL-ORT-39

Details and patient eligibility

About

The aim of this randomized controlled study is to investigate whether the implementation of Blood Flow Restriction, in which the de-loading factor is delivered by the combined progressive de-loaded walking to running activity on an antigravity treadmill (treatment group), is more effective than the same antigravity protocol alone (control group).

Participants will be divided as follows:

Intervention group: anti-gravity treadmill combined with blood flow restriction Control group: anti-gravity treadmill Both groups will also undergo a standardized knee Osteoarthritis management through an aerobic and strength program.

Enrollment

70 estimated patients

Sex

All

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age included between 45 and 80 years old
  • Patients with knee OA diagnosed by a medical doctor with a radiological confirmation
  • Patients able to provide informed consent and follow all the study procedures as indicated by the protocol
  • Informed Consent as documented by signature

Exclusion criteria

  • Younger than 44 years old or older than 81 years old included
  • Known drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
  • Participation in another study with an investigational drug within the 30 days preceding and during the present study
  • Treatment with an injective approach in the previous 3 month
  • Surgical treatment in the previous 12 months.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

Anti-gravity treadmill + Blood Flow Restriction training
Experimental group
Treatment:
Other: Blood flow restriction training + Anti-gravity treadmill
Anti-gravity treadmill
Active Comparator group
Treatment:
Other: Anti-gravity treadmill

Trial contacts and locations

1

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Central trial contact

Sebastiano Nutarelli, MS

Data sourced from clinicaltrials.gov

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