Mobility LimitationNCT03558841
Effect of Lyra Gait Training on the Mobility of Geriatric Rehabilitation Inpatients
A study testing Gait training with the THERA-Trainer Lyra and Physical therapy in people with Mobility Limitation and Muscle Weakness, run by University Department of Geriatric Medicine FELIX PLATTER at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mobility Limitation, Muscle Weakness
- What is being tested?
- Gait training with the THERA-Trainer Lyra and Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Oct 2017to 29 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Gait training with the THERA-Trainer Lyra, Physical therapy
- Keywords
- gait, mobility, geriatric, rehabilitation, inpatient
- Medical subject headings
- Mobility Limitation, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait training with the THERA-Trainer LyraOther
Gait training with the THERA-Trainer Lyra end-effector gait trainer 3x/week during the inpatient and the outpatient periods.
Physical therapyOther
Conventional geriatric rehabilitation physical therapy (6x/week) during the inpatient period. After discharge home, discontinuation of physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Gait training with the THERA-Trainer Lyra; Other: Physical therapy |
| Control Group | Active comparator | Conventional geriatric rehabilitation physical therapy (6x/week) during inpatient period. After discharge home, discontinuation of physical therapy. Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait velocity
Habitual, preferred ("normal") walking speed (cm/s) quantified with the GAITRite electronic walkway system
Measured: Baseline, after 2 weeks, after 4 weeks
Secondary outcomes (9)
Change in grip strength
Grip strength (kg) of each hand (best result of two attempts for each hand used for data analysis)
Measured: Baseline, after 2 weeks, after 4 weeks
Change in general mobility
Timed Up and Go Test time (seconds); faster test times represent better general mobility
Measured: Baseline, after 2 weeks, after 4 weeks
Change in spatial-temporal gait parameters (other than walking velocity)
Gait parameters quantified with the GAITRite electronic walkway system
Measured: Baseline, after 2 weeks, after 4 weeks
Change in endurance
Six Minute Walk Test; distance walked (meters) in six minutes; greater distance walked represents better endurance
Measured: Baseline, after 2 weeks, after 4 weeks
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
Measured: Baseline, after 2 weeks, after 4 weeks
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
Measured: Baseline, after 2 weeks, after 4 weeks
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
Measured: Baseline, after 2 weeks, after 4 weeks
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
Measured: Baseline, after 2 weeks, after 4 weeks
Change in the THERA-Trainer Lyra machine settings
Settings of the THERA-Trainer Lyra gait training machine
Measured: Baseline, after 2 weeks, after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start5 Oct 2017
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
Why it stopped: enrollment goal not met in allotted recruitment period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, active-controlled
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Department of Geriatric Medicine FELIX PLATTER
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel
- Responsible party
- Sponsor
- Investigators
- Stephanie A. Bridenbaugh, M.D, Principal investigator, Head of the Basel Mobility Center of the Felix Platter Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558841
- Sponsor's protocol ID
- BASEC ID 2017-01495
- Other IDs
- SNCTP000002696
- Status last verified
- Jun 2018
- First submitted
- 16 May 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03558841
- Acronym / sponsor ID
- BASEC ID 2017-01495
- Conditions
- Mobility Limitation, Muscle Weakness
- Keywords
- gait, mobility, geriatric, rehabilitation, inpatient
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment goal not met in allotted recruitment period
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Department of Geriatric Medicine FELIX PLATTERUniversity, hospital or other
- Collaborators
- University of Basel
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, active-controlled
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Gait training with the THERA-Trainer Lyra, Other: Physical therapyGait 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. |
| Control Group | Active comparator | Other: Physical therapyConventional geriatric rehabilitation physical therapy (6x/week) during inpatient period. After discharge home, discontinuation of physical therapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait training with the THERA-Trainer LyraGait training with the THERA-Trainer Lyra end-effector gait trainer 3x/week during the inpatient and the outpatient periods. | Other | Intervention Group |
| Physical therapyConventional geriatric rehabilitation physical therapy (6x/week) during the inpatient period. After discharge home, discontinuation of physical therapy. | Other | Control Group, Intervention Group |
Primary outcome
Change in gait velocity
Time frame: Baseline, after 2 weeks, after 4 weeks
Habitual, preferred ("normal") walking speed (cm/s) quantified with the GAITRite electronic walkway system
9 secondary outcomes
Change in grip strength
Time frame: Baseline, after 2 weeks, after 4 weeks
Change in general mobility
Time frame: Baseline, after 2 weeks, after 4 weeks
Change in spatial-temporal gait parameters (other than walking velocity)
Time frame: Baseline, after 2 weeks, after 4 weeks
Change in endurance
Time frame: Baseline, after 2 weeks, after 4 weeks
Change in functionality (DEMMI total score, absolute values)
Time frame: Baseline, after 2 weeks, after 4 weeks
Change in functionality (DEMMI total score, scaled values)
Time frame: Baseline, after 2 weeks, after 4 weeks
Change in fear of falling
Time frame: Baseline, after 2 weeks, after 4 weeks
Change in subjective intensity of the Lyra training
Time frame: Baseline, after 2 weeks, after 4 weeks
Change in the THERA-Trainer Lyra machine settings
Time frame: Baseline, after 2 weeks, after 4 weeks
Results and safety
The study was stopped early (reason given: enrollment goal not met in allotted recruitment period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Mobility Limitation
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
Recruiting
Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort
Joint Osteoarthritis, Atherosclerosis of the Distal Arteries, Without Gangrene
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
RecruitingObservational study
Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie A. Bridenbaugh, M.D principal investigator
Head of the Basel Mobility Center of the Felix Platter Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait training with the THERA-Trainer Lyra and Physical therapy in people with Mobility Limitation and Muscle Weakness, run by University Department of Geriatric Medicine FELIX PLATTER at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: enrollment goal not met in allotted recruitment period). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait velocity (time frame: Baseline, after 2 weeks, after 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.