A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability

Conditions

• Instability; Ankle (Ligaments) (Old Injury)
• Sprain of Ankle

Eligibility Criteria

Sex

ALL

Age

18 Years - 49 Years

Healthy Volunteers

Not accepted

Interventions

• Uneven Treadmill Intervention — OTHER
  Progressive proprioceptive training on the uneven treadmill with up to twelve training sessions. Subjects will be advanced through activities with progression pragmatically assessed by the physical therapists for the benefit and tolerance of the individual subject. Activities may include: slow walking, fast walking, inclined/declined walking, head turning, vision obstruction, dual task walking, fatigued walking, load carriage. Standard of care physical therapy is still provided.
• Standard of Care Physical Therapy — OTHER
  Standard of Care Physical Therapy

Study Details

The ROCKY REHAB trial will provide a pragmatic approach to evaluate if incorporating a rocky, uneven terrain treadmill into the proprioceptive rehabilitation received during physical therapy can improve outcomes and reduce reinjury rates in patients with ankle instability.

Key Dates

Start date

Nov 23, 2021

Status verified

Jul 2025

Primary completion

Sep 30, 2025

Completion

Sep 30, 2026

Study Design

Enrollment

312 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Uneven Treadmill Arm
  Uneven Treadmill Intervention with up to twelve sessions over approximately six weeks and Standard of Care Physical Therapy with an 18 month follow-up period
• Active Comparator: Control Arm
  Standard of Care Physical Therapy over approximately six weeks with an 18 month follow-up period

Primary Outcome Measure

Change in the Cumberland Ankle Instability Tool [ Time Frame: Baseline assessment (0 weeks), first ( 2 weeks) and second (4 weeks) interim assessments, discharge assessment (6 weeks) and follow-up assessments at 3, 6, 9, 12, 15, and 18 months. ]

Central Contacts

• Pinata Sessoms, PhD
  619-553-7760
  [email protected]
• Sara Gorczynski, PT DPT
  619-532-9704
  [email protected]

Locations (2)

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