Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients

Status Recruiting

Clinical Trial Summary

The overall objective of this study is to compare outcomes following early versus delayed weight bearing for adult patients operatively treated for an ankle fracture without syndesmotic fixation. Additionally, early weight bearing will be tested in patients with unicondylar plateau fractures that do not involve joint impaction in the context of a pilot study.

Clinical Trial Description

The purpose of this multi-center, randomized controlled trial (RCT) is to compare outcomes following early versus delayed weight bearing among individuals with a traumatic ankle fracture. This study will enroll patients ages 18 or older surgically treated for an ankle fracture or fracture dislocation (without syndesmosis) at participating civilian trauma centers and military treatment facilities. Eligible patients will be identified during hospitalization for definitive treatment and enrolled prior to discharge or at the first post op clinic visit. Patients that consent to participate will complete a baseline assessment at the first post op clinic visit and will be randomized to early versus delayed weight bearing. Both treatment groups will receive standardized exercises that can be done at home or with a therapist. Outcomes will be evaluated at 6 weeks, 3, 6 and 12 months following definitive fracture fixation. All 6 week, 3 and 6 month evaluations will take place in the surgeon's outpatient clinic and involve clinical and radiographic assessments of healing as well as functional outcome surveys. The 12 month evaluation will be conducted by phone except for individuals who were judged not to be healed (clinically or radiographically) at 6 months; these participants will be asked to return for their 12 month evaluation (to assess healing). Simultaneously, a pilot RCT will be conducted in patients 18 or older surgically treated with a unicondylar plateau fracture without joint impaction. ;

Study Design

Related Conditions & MeSH terms

Rehabilitation

Clinical Trial Details

NCT number	NCT04028414
Study type	Interventional
Source	Major Extremity Trauma Research Consortium
Contact	ELIZABETH WYSOCKI, MS
Phone	4109550396
Email	ewysock2@jhu.edu
Status	Recruiting
Phase	N/A
Start date	January 1, 2020
Completion date	September 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04458480` - Effect of Fast Inpatient Rehabilitation After TKA
Recruiting	`NCT06238596` - Rehabilitation Intervention to Prevent Adverse Events Related to Androgen-deprivation Therapy (ADT) in Patients With Metastatic Prostate Cancer (PCa): a Single Arm Feasibility Study (ReCaP Study)	N/A
Recruiting	`NCT05547152` - Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis	N/A
Active, not recruiting	`NCT05520528` - Impact of Group Participation on Adults With Aphasia	N/A
Completed	`NCT03661944` - Functional Performance Assessments in Overhead Athletes With Shoulder Injury
Completed	`NCT05875480` - The Effectiveness of Telerehabilitation After Arthroscopic Meniscus Repair	N/A
Not yet recruiting	`NCT05854056` - Tibial Tubercle Distalisation and Accelerated Rehabilitation	N/A
Not yet recruiting	`NCT05177380` - Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis	N/A
Not yet recruiting	`NCT04419753` - The Role of Attention Focus Walking Training in Older Adults.	N/A
Not yet recruiting	`NCT03628495` - Effectiveness of a Combined Pressure and Silicone Intervention for Hypertrophic Scar Treatment	N/A
Completed	`NCT02413996` - Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty	N/A
Completed	`NCT01205542` - Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function	N/A
Completed	`NCT02644096` - Rehabilitation of Patients After THR - Based on Patients´Selfrated Health	Phase 1
Completed	`NCT03582371` - Aqua Stand-Up Paddle Balance Effect in Parkinson's Disease (AquaSUP PARK)	N/A
Completed	`NCT05655039` - The Effect of Pre-rehabilitation and Rehabilitation Period on Functional Status in Inpatient Stroke Patients
Completed	`NCT04502654` - Rehabilitation for Thoracoscopic Lobectomy
Completed	`NCT06206018` - Patient-Reported Outcome Measures in Lower Extremity Rehabilitation Program PROM_R: Impact on Health Care	N/A
Completed	`NCT03386604` - Physical Capacity of Patients With Chronic Obstructive Pulmonary Disease With and Without Supplementation of Whey	N/A
Recruiting	`NCT05619666` - Acute Rehabilitation in Patients With COVID-19 Pneumonia	N/A
Completed	`NCT06251791` - Inspiratory Muscle Training and Expiratory Muscle Thickness	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial Plateau Fractures

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms