NCT05165927

Comparison of Methods in Post Operative Hip Arthroscopy Rehabilitation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The investigators plan to investigate the efficacy of blood flow restriction (BFR) therapy in post operative rehabilitation following hip arthroscopy. BFR has shown to be great at helping the recovery process. SAGA is a well-known smart training technology company, and the investigators aim to partner with SAGA to use the BFR cuffs as the intervention method. The BFR cuff will be added to the current SOC for hip scope PT for the intervention group.

Detailed description

Study Design and Research Methods i. Timeline: Treatment Protocol duration 12 weeks per participant beginning post operative day 1 following hip arthroscopy. PRO's will be collected out to 2 years post-surgery and standard rehabilitation will follow the 12-week intervention period for both the control and experimental group. Study will be a 2-year timeline in total. ii. Procedures: Patients will be randomized to control group, who will undergo Steadman Hawkins Clinic Denver's standard hip arthroscopy rehab protocol (see appendix) or to the intervention group, who will undergo standard rehab protocol with addition of BFR. Subjects will be randomized 1:1 for intervention vs. control and controlled for gender assigned at birth. iii. Frequency of BFR Training: 6 days per week phase 1, 3 days per week phases 2 and 3 iv. Frequency of clinic visits PT: 1 day per week v. Intervention Group: The following exercises outlined are the specific exercises that will be performed in addition to SOC. Only these exercises will involve the use of the BFR cuff. 1. Phase 1 (post operative weeks 1-3) 1. Dosage: 80% limb occlusion pressure (LOP). 30x15x15x15 repetitions with 30 sec rests between sets. At least 1 min rest between exercises with occlusion OFF. 2. Frequency: All 3 exercises performed at least 6 days per week. The first of these sessions will be performed in clinic supervised by PT to assess LOP and form prior to performance at home 3. Exercises: i. Week 1: quadriceps set, gluteal set, hamstring set ii. Week 2: short arc quad, hook lying adduction/internal rotation isometric, hook lying abduction/external rotation isometric iii. Week 3: long arc quad, bridge, standing hamstring curl 2. Phase 2 (weeks 4-6) 1. Dosage: 80% LOP. 30x15x15x15 repetitions with 30 sec rests between sets. At least 1 min rest between exercises with occlusion OFF 2. Frequency: All 3 resistive exercises performed at least 3 days per week. The first of these sessions will be performed in clinic supervised by PT to assess LOP and form prior to performance at home 3. Exercises: i. Week 4: mini squat, prone hip extension over plinth, quadruped rock ii. Week 5: mid-range squat, modified single leg bridge foot on ball, heel slide strap assist iii. Week 6: step up, standing hip abduction, single leg bridge 3. Phase 3 (weeks 6-12) a. Dosage: 80% LOP at 20-30% 1 RM.1 RM re-evaluated every 2 weeks to adjust resistance prescription. 30x15x15x15 repetitions with 30 sec rests between sets. At least 1 min rest between exercises with occlusion OFF b. Frequency: All 3 resistive exercises performed at least 3 days per week. The first of these sessions will be performed in clinic supervised by PT to assess LOP and form prior to performance at home c. Exercises: i. Weeks 6-12: Single leg squat to 45 deg knee flexion (holding weight as tolerated), single leg Romanian dead lift (holding weight a weight as tolerated), Bulgarian split squat (holding a weight as tolerated) 4. Phase 4 (12+ weeks) a. BFR intervention will be discontinued at 12 weeks and participants will progress per standard protocol for the remainder of their rehabilitation course vi. Control Group 1\. Control group will follow the standard of care outlined in Appendix A. vii. Criteria for progression within the BFR specific exercise protocol 1\. Regardless of functional performance, patients will not be allowed to progress ahead of the time-based exercise prescription in the BFR protocol. However, if the treating therapist determines that the current week's exercise prescription is too difficult for the patient, subject may return to the prior week's exercise set until able to advance.

Conditions

• Hip Injuries

Interventions

Type	Name	Description
DEVICE	BFR	BFR cuffs will be used at home during specified exercises in addition to SOC for post hip scope PT.

Timeline

• Start date: 2022-04-29
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-12-21
• Last updated: 2024-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study