Effect of Lyra Gait Training on the Mobility of Geriatric Rehabilitation Inpatients

NCT ID: NCT03558841

Last Updated: 2018-06-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-05
• Study Completion Date: 2018-03-29

Brief Summary

This study evaluates the effect of the addition of gait training to physical therapy on the gait of geriatric rehabilitation inpatients. Half of the patients will receive gait training with a gait training machine and conventional physical therapy in combination, the other half of the patients will receive conventional physical therapy alone.

Detailed Description

The geriatric rehabilitation inpatients recruited for this study primarily have difficulties with muscle weakness and walking generally due to a prolonged period of bed rest (as opposed to patients who primarily have cognitive disorders or neurological diseases), generalized muscle weakness and deconditioning. The rehabilitation goal for these patients is to be discharged home (not institutionalized) with improved mobility. Geriatric patients require intensive training in order to reach their pre-hospital levels of mobility and physical functional performance. Usual care involves physical therapy sessions, generally six times per week. Regaining mobility is crucial for quality of life and functional independence.

The aim of this intervention trial is to compare the effectiveness of Lyra gait training plus conventional physical therapy (intervention group) on gait compared to conventional physical therapy alone (control group) in geriatric rehabilitation patients. We hypothesize that, post-intervention, the intervention group will have better mobility and physical functional performance than the control group. Trial results will provide physical therapists and rehabilitation physicians with valuable information to better treat their inpatients and more efficiently use the limited time available for inpatient physical therapy sessions. Specifically, physical therapists should be better able to determine if the benefit of the Lyra gait trainer for geriatric rehabilitation inpatients with primarily muscle deconditioning is strong enough to warrant their extra time investment of providing the Lyra gait training. Results should also help determine in the future if the target population should continue with outpatient therapy after their discharge home. If this trial supports our hypothesis, then the trial results will provide data needed for the sample size calculation for a subsequent, larger trial.

The THERA-Trainer Lyra (from Ability AG, distributed by medica Medizintechnik GmbH) is an automated gait trainer with adjustable body weight support (no exoskeleton) and adjustable pedals (not a treadmill) that move in a physiological gait pattern derived from natural human walking movements. The upright position and the repetitive movement patterns activate muscle memory and allow safe gait training at the individual's performance limit throughout rehabilitation. The Lyra gait training is used to regain walking ability, improve gait speed, improve endurance and improve the gait pattern in geriatric rehabilitation patients.

Ten patients should be enrolled in this study:

Intervention group (n=5): Lyra gait training thrice weekly and conventional physical therapy (6 times per week) during inpatient period. After discharge home, continuation of thrice weekly Lyra gait training and discontinuation of physiotherapy.

Control group (n=5): Conventional physical therapy (6 times per week) during inpatient period. After discharge home, discontinuation of physical therapy.

At enrollment (Visit 1), all participants will be rehabilitation inpatients. The duration of the inpatient period will be determined clinically based on medical need and will thus vary from patient to patient. The average length of stay for the targeted population is approximately two weeks. Visit 2 will be performed shortly before the patient is discharged home. For each participant, the outpatient period (between Visit 2 and Visit 3) will be the same duration as the inpatient period (between Visit 1 and Visit 2).

Conditions

Mobility Limitation; Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

Gait training with the THERA-Trainer Lyra (3x/week) in addition to conventional geriatric rehabilitation physical therapy (6x/week) during inpatient period. After discharge home, continuation of Lyra gait training (3x/week), discontinuation of physical therapy.

Group Type: EXPERIMENTAL

Gait training with the THERA-Trainer Lyra

Intervention Type: OTHER

Gait training with the THERA-Trainer Lyra end-effector gait trainer 3x/week during the inpatient and the outpatient periods.

Physical therapy

Intervention Type: OTHER

Conventional geriatric rehabilitation physical therapy (6x/week) during the inpatient period. After discharge home, discontinuation of physical therapy.

Control Group

Conventional geriatric rehabilitation physical therapy (6x/week) during inpatient period. After discharge home, discontinuation of physical therapy.

Group Type: ACTIVE_COMPARATOR

Physical therapy

Intervention Type: OTHER

Conventional geriatric rehabilitation physical therapy (6x/week) during the inpatient period. After discharge home, discontinuation of physical therapy.

Interventions

Gait training with the THERA-Trainer Lyra

Gait training with the THERA-Trainer Lyra end-effector gait trainer 3x/week during the inpatient and the outpatient periods.

Intervention Type: OTHER

Physical therapy

Conventional geriatric rehabilitation physical therapy (6x/week) during the inpatient period. After discharge home, discontinuation of physical therapy.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 65 years of age or older
• Rehabilitation inpatients at Felix Platter Hospital with primarily muscle weakness and difficulty walking
• Community-dwellers before hospital admission with planned discharge home
• Body weight 150 kg or less
• Body height between 100 cm and 195 cm
• Mini-Mental State Examination score 21 points or more
• Signed informed consent for study participation

Exclusion Criteria

• Clinically significant neurologic or musculoskeletal diseases which severly affect walking, e.g. advanced Parkinson's disease or hemiplegia
• Severe cardiac insufficiency
• Advanced chronic pulmonary disease (COPD Gold IV)
• Amputations of extremities (except missing fingers)
• Blindness
• Inability to understand and speak German well enough to understand the patient information, training and assessment instructions

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Basel

OTHER

Sponsor Role: collaborator

University Department of Geriatric Medicine FELIX PLATTER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie A. Bridenbaugh, M.D

Role: PRINCIPAL_INVESTIGATOR

Head of the Basel Mobility Center of the Felix Platter Hospital

Locations

Felix Platter Hospital

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

SNCTP000002696

Identifier Type: OTHER

Identifier Source: secondary_id

BASEC ID 2017-01495

Identifier Type: -

Identifier Source: org_study_id