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

NCT03558841 | Terminated

• 2 other identifiers: BASEC ID 2017-01495SNCTP000002696
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Mobility Limitation; Muscle Weakness

Keywords

gait; mobility; geriatric; rehabilitation; inpatient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in grip strength

  Baseline, after 2 weeks, after 4 weeks

• Change in general mobility

  Baseline, after 2 weeks, after 4 weeks

• Change in spatial-temporal gait parameters (other than walking velocity)

  Baseline, after 2 weeks, after 4 weeks

• Change in endurance

  Baseline, after 2 weeks, after 4 weeks

• Change in functionality (DEMMI total score, absolute values)

  Baseline, after 2 weeks, after 4 weeks

Study Arms (2)

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.

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.

Other: Physical therapy

Interventions

Gait training with the THERA-Trainer Lyra OTHER

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

Intervention Group

Physical therapy OTHER

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

Control Group; Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Department of Geriatric Medicine FELIX PLATTER: lead
• University of Basel: collaborator

Study Sites (1)

Felix Platter Hospital

Basel, 4002, Switzerland

Location

MeSH Terms

Conditions

Mobility Limitation; Muscle Weakness

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Stephanie A. Bridenbaugh, M.D

  Head of the Basel Mobility Center of the Felix Platter Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, active-controlled

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 15, 2018
• Study Start: October 5, 2017
• Primary Completion: March 29, 2018
• Study Completion: March 29, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

CH (1)