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

Primary Purpose

Brain Ischemia, Intracranial Haemorrhage

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Andago V2.0
Sponsored by
Rehaklinik Zihlschlacht AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Any medical condition preventing active rehabilitation and/or the use of the Andago V2.0 (e.g., respiratory disease, pregnancy, orthopedic conditions, infections or inflammatory disorders, osteomyelitis)
  • Participation in another interventional study within the 30 days preceding and during the present study

Sites / Locations

  • Rehaklinik Zihlschlacht, Center for Neurological Rehabilitation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

In this arm the Andago V2.0 is used.

Outcomes

Primary Outcome Measures

Usability of the IMD according to the number of participants that are able to use the Andago V2.0
Acceptance of the IMD as measured by a therapist satisfaction questionnaire
Acceptance of the IMD as measured by a patient satisfaction questionnaire

Secondary Outcome Measures

Full Information

First Posted
March 15, 2016
Last Updated
September 27, 2018
Sponsor
Rehaklinik Zihlschlacht AG
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1. Study Identification

Unique Protocol Identification Number
NCT02735460
Brief Title
Usability of Andago V2.0 in Gait Rehabilitation of Stroke Patients
Official Title
Single-center Usability Study of the Overground Gait and Balance Training Device Andago V2.0 in Patients With Gait Disorder After Stroke at a Center for Neurological Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
February 3, 2017 (Actual)
Study Completion Date
February 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rehaklinik Zihlschlacht AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Ischemia, Intracranial Haemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
In this arm the Andago V2.0 is used.
Intervention Type
Device
Intervention Name(s)
Andago V2.0
Intervention Description
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.
Primary Outcome Measure Information:
Title
Usability of the IMD according to the number of participants that are able to use the Andago V2.0
Time Frame
3 weeks
Title
Acceptance of the IMD as measured by a therapist satisfaction questionnaire
Time Frame
3 weeks
Title
Acceptance of the IMD as measured by a patient satisfaction questionnaire
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) Any medical condition preventing active rehabilitation and/or the use of the Andago V2.0 (e.g., respiratory disease, pregnancy, orthopedic conditions, infections or inflammatory disorders, osteomyelitis) Participation in another interventional study within the 30 days preceding and during the present study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Detlef Marks
Organizational Affiliation
Rehaklinik Zihlschlacht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehaklinik Zihlschlacht, Center for Neurological Rehabilitation
City
Zihlschlacht
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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