Usability of Andago V2.0 in Gait Rehabilitation of Stroke Patients

NCT02735460 | Completed

• 1 other identifier: RZI_01_2015
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Andago V2.0 is a recently developed overground gait and balance training device. Many patients in neurorehabilitation suffer from gait disorders, most typically after stroke. Since pharmacological therapies are basically not available, neurorehabilitation plays an important role in the treatment of such patients. The Andago V2.0 may represent a useful device in the rehabilitation of stroke and other neurological patients featuring a severe gait disorder. Therefore a study has been designed to investigate the usability of the Andago V2.0 in the setting of a neurorehabilitation clinic. The primary outcomes of this study are the usability and acceptance of the investigational medical device (IMD). Usability is mainly measured by the time spent for the set-up and release of the participant, achieved training times and distances, the number of stumbles, collisions and emergency stops and the error messages during the session. Besides patient and therapist satisfaction with the Andago V2.0 is recorded.

Conditions

Brain Ischemia; Intracranial Haemorrhage

Outcome Measures

Primary Outcomes (3)

• Usability of the IMD according to the number of participants that are able to use the Andago V2.0

  3 weeks

• Acceptance of the IMD as measured by a therapist satisfaction questionnaire

  3 weeks

• Acceptance of the IMD as measured by a patient satisfaction questionnaire

  3 weeks

Study Arms (1)

Treatment arm

EXPERIMENTAL

In this arm the Andago V2.0 is used.

Device: Andago V2.0

Interventions

Andago V2.0 DEVICE

The Andago V2.0 is tested in 2 sessions, the first being a training session to define the probably optimal settings for the subsequent therapy session. In the therapy session the participant performs a specific parcours. Usually this parcours can be done within 10 minutes. However, the session is stopped as soon as the patient feels too exhausted or becomes too weary.

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent as documented by signature
• Primary diagnosis of cerebral infarction (ICD-10: I63.0-I63.9) or intracerebral haemorrhage (ICD-10: I61.0-I69.9) independent of its location, age or cause
• Gait disorder defined by a category of 1 to 3 on the Functional Ambulation Classification (FAC) (17)
• Age above 18 years
• Admission to Rehaklinik Zihlschlacht for in-patient neurorehabilitation

You may not qualify if:

• Inability of the participant to understand the informed consent or to follow the procedures of the study, e.g., due to language problems, psychiatric disorders, cognitive impairment or aphasia (item 9 of the National Institute of Health Stroke Scale (NIHSS) ≥2)
• Weight \>135 kg
• Height \>200 cm
• Bone fragility (e.g., non-consolidated fractures or osteotomies including craniotomies, osteopenia, osteoporosis or symptoms or indices in the patient history that infer a higher risk of bone density reduction)
• Unstable arthroplasty
• Uncontrolled knee or ankle instability that would still pose a danger despite the Body Weight Support (BWS) (especially lateral instability)
• Lack of head control
• Joint contractures
• Relevant differences in leg length
• Skin lesions (including pressure sores or enteric stomata) in areas of contact with harness support or lower extremity loading (feet)
• Relevant sensory impairment in the lower limbs and trunk, especially with reduced pain sensation
• Recent history or significant risk of seizures
• Relevant cardiovascular conditions, e.g., cardiac insufficiency and thoracotomy, uncontrolled orthostatic hypotension or other circulatory problems, vascular disorders of the lower limbs
• Mechanical ventilation
• Long-term infusions (e.g., baclofen pump, other intrathecal pumps)

Sponsors & Collaborators

• Rehaklinik Zihlschlacht AG: lead

Study Sites (1)

Rehaklinik Zihlschlacht, Center for Neurological Rehabilitation

Zihlschlacht, Switzerland

Location

MeSH Terms

Conditions

Brain Ischemia; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Detlef Marks

  Rehaklinik Zihlschlacht

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: April 12, 2016
• Study Start: March 1, 2016
• Primary Completion: February 3, 2017
• Study Completion: February 3, 2017
• Last Updated: October 1, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)