Other Clinical Trial - Evaluation of a Motorised Prosthetic Knee

Status Not yet recruiting

Clinical Trial Summary

The study will investigate the effect over time of the Power Knee (Össur) on performance during daily activities in people with a unilateral transfemoral amputation, will determine subjective feelings and gait kinematics over time during daily activities and will investigate the association between subjective feelings and objective outcomes of performing daily activities.

Clinical Trial Description

Participants will visit the lab 6 times over a period of 5 weeks. The study includes a familiarisation phase (3 measuring moments) followed by the experimental phase (3 measuring moments). During the measuring sessions, participants will perform four tasks with their current prosthesis and with the Power Knee (Össur). The order in which the devices will be tested, will be reversed on each measuring moment to control for possible order effects and fatigue. The experimental protocol will entail an L-test and slope walking test that will each be performed 3 times, followed by a 6 minutes of hallway walking (6MWT), 10 min rest and a dual-task 6MWT. The slope walking test assesses the participants' ability to ascend and descend a 6 m long ramp of 10% inclination as fast as possible. For safety reasons bilateral handrails are warranted. Participants start the test in an upright position in front of the ramp and are asked to ascend the ramp, turn around on the platform, descend the ramp and return to the starting position. The L-test, requires higher physical activity of the user. During the L-test, participants are asked to rise from a chair, walk 7 meters, turn 90 degrees, walk 3 meters, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter is covered. The 6MWT will be performed on a hallway at a self-selected walking speed, which closely relates to the most efficient walking speed. The dual-task 6MWT will be compiled out of conducting a 6MWT while performing a cognitive task, i.e. serial subtractions. Serial subtraction is mental arithmetic task that tests attention and working memory. Participants will be asked to continually subtract sevens from a random selected 3-digit number as long as the duration of the test. ;

Study Design

Related Conditions & MeSH terms

Lower Limb Amputation Above Knee (Injury)

Clinical Trial Details

NCT number	NCT05407545
Study type	Interventional
Source	Vrije Universiteit Brussel
Contact	Kevin De Pauw
Phone	+32 (0)2 629 27 53
Email	Kevin.De.Pauw@vub.be
Status	Not yet recruiting
Phase	N/A
Start date	April 2023
Completion date	August 2023

View Details

See also
Status	Clinical Trial	Phase
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Recruiting	`NCT05915065` - VR to Evaluate Phantom Limb Pain	N/A
Recruiting	`NCT05267639` - Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees	N/A
Completed	`NCT03673371` - Women's-Specific Footwear With Prosthetic Feet
Completed	`NCT04239222` - Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot	N/A
Recruiting	`NCT06017024` - New Microprocessor-Controlled Prosthetic Knee Evaluation	N/A
Completed	`NCT02240186` - Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees	N/A
Active, not recruiting	`NCT04784429` - Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population	N/A
Not yet recruiting	`NCT06419920` - Prosthetic Performance Enhancement Trial	N/A
Recruiting	`NCT04937179` - The Effect of Ischemic Conditioning on Strength and Ambulation in Subjects With PAD	N/A
Recruiting	`NCT04129853` - The CYBERnetic LowEr Imb coGnitive Ortho-prostheis Plus Plus, 2nd Clinical Study (CLs++)	N/A
Completed	`NCT03338842` - Virtual Reality Treatment for Phantom Limb Pain	N/A
Completed	`NCT05601349` - TeleEducation for Implementing a Clinical Practice Guideline For Amputees	N/A
Not yet recruiting	`NCT03376919` - The CYBERnetic Lower Limb Cocognitive Ortho-prosthesis Plus Plus, 1st Clinical Study (CLs++)	N/A
Completed	`NCT04700085` - Reverse Innovation in Western Health Care: the ReMotion Prosthetic Knee.	N/A
Completed	`NCT04051164` - Progressive Muscle Relaxation Technique on Lower Limb Amputation	N/A
Recruiting	`NCT04217005` - Enhancing Abilities in Amputees and Patients With Peripheral Neuropathy Through Restoration of Sensory Feedback	N/A
Recruiting	`NCT05471375` - C-STAR Movement Database
Not yet recruiting	`NCT04953364` - Self-Management for Amputee Rehabilitation Using Technology.	N/A
Completed	`NCT05803317` - Asymmetry of the Center of Pressure During Gait After Amputation of Lower Limbs

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.

Evaluation of a Motorised Prosthetic Knee — MOKI-B

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms