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

Muscle Weakness Clinical Trial

Official title:

Effect of THERA-Trainer Lyra Gait Training in Addition to Physical Therapy on the Mobility of Geriatric Rehabilitation Inpatients Compared to Physical Therapy Alone: Randomized, Active-controlled, Parallel Group, Intervention Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03558841
• Other study ID #: BASEC ID 2017-01495
• Secondary ID: SNCTP000002696
• Status: Terminated
• Phase: N/A
• Start date: October 5, 2017
• Est. completion date: March 29, 2018

Study information

• Verified date: June 2018
• Source: Felix Platter Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 29, 2018
• Est. primary completion date: March 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mobility Limitation
• Muscle Weakness
• Paresis

Intervention

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

Locations

Country	Name	City	State
Switzerland	Felix Platter Hospital	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Felix Platter Hospital	University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gait velocity	Habitual, preferred ("normal") walking speed (cm/s) quantified with the GAITRite electronic walkway system	Baseline, after 2 weeks, after 4 weeks
Secondary	Change in grip strength	Grip strength (kg) of each hand (best result of two attempts for each hand used for data analysis)	Baseline, after 2 weeks, after 4 weeks
Secondary	Change in general mobility	Timed Up and Go Test time (seconds); faster test times represent better general mobility	Baseline, after 2 weeks, after 4 weeks
Secondary	Change in spatial-temporal gait parameters (other than walking velocity)	Gait parameters quantified with the GAITRite electronic walkway system	Baseline, after 2 weeks, after 4 weeks
Secondary	Change in endurance	Six Minute Walk Test; distance walked (meters) in six minutes; greater distance walked represents better endurance	Baseline, after 2 weeks, after 4 weeks
Secondary	Change in functionality (DEMMI total score, absolute values)	The de Morton Mobility Index (DEMMI) assesses functionality in different positions (lying, sitting, standing, walking); absolute values range from zero to 19 points; higher scores reflect better functionality	Baseline, after 2 weeks, after 4 weeks
Secondary	Change in functionality (DEMMI total score, scaled values)	The de Morton Mobility Index (DEMMI) assesses functionality in different positions (lying, sitting, standing, walking); scaled scores range from zero to 100 points; higher scores reflect better functionality	Baseline, after 2 weeks, after 4 weeks
Secondary	Change in fear of falling	Subjective fear of falling assessed by self-report using the "Falls Efficacy Scale-International Version (FES-I)" questionnaire; results range from 16 to 64 Points; higher scores reflect greater fear of falling; total number of points will be analysed	Baseline, after 2 weeks, after 4 weeks
Secondary	Change in subjective intensity of the Lyra training	Subjective intensity assessed by self-report using the "Borg Rating of Perceived Exertion Scale" questionnaire; score range from 6 (no exertion at all) to12 (maximal exertion); higher scores represent greater subjective intensity and exertion of the Intervention training	Baseline, after 2 weeks, after 4 weeks
Secondary	Change in the THERA-Trainer Lyra machine settings	Settings of the THERA-Trainer Lyra gait training machine	Baseline, after 2 weeks, after 4 weeks