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Balance Training After Stroke - a Randomized, Controled Pilot Study

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
individual balance training
group balance training
Sponsored by
RehaClinic AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Balance training, Gait Speed

Eligibility Criteria

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

Inclusion Criteria:

  • stroke starting from Rehabilitation phase B
  • ability to understand therapy instructions
  • walkable with aids

Exclusion Criteria:

  • Neurodegenerative disease
  • non-stroke dizziness
  • cardiopulmonary insufficiency
  • polyneuropathy
  • peripheral vascular disease

Sites / Locations

  • RehaClinic Kilchberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

individual balance training

group balance training

Arm Description

After the initial assessments, the three week intervention time begins, which is completed with the reassessments. The patients receive 2x weekly individual balance training for 25 minutes each. This runs in addition to the normal, prescribed rehabilitation program. The rehabilitation program includes at least 3 therapies daily. These may be group therapies, speech therapy, occupational therapy, neuropsychology and physiotherapy adapted to the needs of the patient. In physiotherapy and occupational therapy no balance training will be performed during the intervention period.

The patients receive 2x weekly group balance training for 25 minutes each. This runs in addition to the normal, prescribed rehab program. The rehabilitation program includes at least 3 therapies daily. These may be group therapies, speech therapy, occupational therapy, neuropsychology and physiotherapy adapted to the needs of the patient. In physiotherapy and occupational therapy no balance training will be performed during the intervention period. In group therapy are 3 to 6 patients with different neurological diagnoses. As it is usual in rehabilitation everyday life.

Outcomes

Primary Outcome Measures

Change of the walking speed at three weeks
10m walking test

Secondary Outcome Measures

Change of the balance score at three weeks
The Berg Balance Scale is used to determine the risk of falling. The BBS detects deficits at both activity and body function levels. It consists of 14 items. Some items require that the patient maintains positions of increasing difficulty, from sitting to standing on one leg. Other items evaluate the ability to perform specific tasks, such as reaching forward, turning around and picking up an object from the floor. Scoring is based on the ability to meet certain time or distance requirements and to perform the items independently. Scaling takes place from 0 points (not possible) to 4 points (independently possible). This results in a total score of 56 points. The cut-off is at 45 points.
Change of the Walking ability (walking aid) at three weeks
Functional Ambulation categories - is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. To use the FAC, an assessor asks the subject various questions and briefly observes their walking ability to provide a rating from 0 to 5. A score of 0 indicates that the patient is a non-functional ambulator (cannot walk); A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3). A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score).

Full Information

First Posted
December 20, 2018
Last Updated
June 27, 2019
Sponsor
RehaClinic AG
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1. Study Identification

Unique Protocol Identification Number
NCT03791671
Brief Title
Balance Training After Stroke - a Randomized, Controled Pilot Study
Official Title
Individual Balance Training vs. Group Balance Training to Improve Walking Speed Post Stroke - a Randomized, Controled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RehaClinic AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot study is part of a master's thesis. In the rehabilitation of stroke patients should be compared whether individual balance training has a greater effect than group balance training. The result is determined based on the walking speed.
Detailed Description
The RehaClinic Kilchberg is a neurological rehabilitation facility with the phases B-D. Between February and the end of March, out of 78 patients, 71% of the patients had a stroke. Therefore, my choice of topic for the Master's thesis fell on balance training of patients after a stroke. The duration of the study is based on the timetable for the Master's thesis. Initially, 20 stroke patients will be recruited. When the number is reached, the study is completed to begin descriptive statistics and analyze potential BIAS. Deficits in the vestibular, visual, motor, and / or somatosensory systems lead to falls in the first 6 months after the stroke. This affects approximately 46% of patients. But also cognitive processes, such as attention and concentration. Therefore, the treatment must be adapted to the respective strategy of the patient. If the patient increasingly uses the visual system, the therapy has to work a lot with the eyes closed. In turn, if he uses more of the sensorimotor system is increasingly trained with unstable documents. After this system, the balance program was set up. It is the same for the intervention and control group to make a difference between individual and group training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Balance training, Gait Speed

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There will be a intervention group and a control group. Both groups do active treatment. In the intervention group they will have individual balance training and in the control group they will have balance training in a group from 3-6 persons. But both groups will do the same balance program.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
individual balance training
Arm Type
Experimental
Arm Description
After the initial assessments, the three week intervention time begins, which is completed with the reassessments. The patients receive 2x weekly individual balance training for 25 minutes each. This runs in addition to the normal, prescribed rehabilitation program. The rehabilitation program includes at least 3 therapies daily. These may be group therapies, speech therapy, occupational therapy, neuropsychology and physiotherapy adapted to the needs of the patient. In physiotherapy and occupational therapy no balance training will be performed during the intervention period.
Arm Title
group balance training
Arm Type
Active Comparator
Arm Description
The patients receive 2x weekly group balance training for 25 minutes each. This runs in addition to the normal, prescribed rehab program. The rehabilitation program includes at least 3 therapies daily. These may be group therapies, speech therapy, occupational therapy, neuropsychology and physiotherapy adapted to the needs of the patient. In physiotherapy and occupational therapy no balance training will be performed during the intervention period. In group therapy are 3 to 6 patients with different neurological diagnoses. As it is usual in rehabilitation everyday life.
Intervention Type
Other
Intervention Name(s)
individual balance training
Intervention Description
One physiotherapist trains one Patient nearby a bar. The tasks changes in gage, visual feedback, vestibular feedback and underground. The Positions will be hodl for 10-30 seconds.
Intervention Type
Other
Intervention Name(s)
group balance training
Intervention Description
Like the individual balance training
Primary Outcome Measure Information:
Title
Change of the walking speed at three weeks
Description
10m walking test
Time Frame
Measurement one day before and one day after the three weeks intervention time, Data analysis through study completion
Secondary Outcome Measure Information:
Title
Change of the balance score at three weeks
Description
The Berg Balance Scale is used to determine the risk of falling. The BBS detects deficits at both activity and body function levels. It consists of 14 items. Some items require that the patient maintains positions of increasing difficulty, from sitting to standing on one leg. Other items evaluate the ability to perform specific tasks, such as reaching forward, turning around and picking up an object from the floor. Scoring is based on the ability to meet certain time or distance requirements and to perform the items independently. Scaling takes place from 0 points (not possible) to 4 points (independently possible). This results in a total score of 56 points. The cut-off is at 45 points.
Time Frame
Measurement one day before and one day after the three weeks intervention time, Data analysis through study completion
Title
Change of the Walking ability (walking aid) at three weeks
Description
Functional Ambulation categories - is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. To use the FAC, an assessor asks the subject various questions and briefly observes their walking ability to provide a rating from 0 to 5. A score of 0 indicates that the patient is a non-functional ambulator (cannot walk); A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3). A score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score).
Time Frame
Measurement one day before and one day after the three weeks intervention time, Data analysis through study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stroke starting from Rehabilitation phase B ability to understand therapy instructions walkable with aids Exclusion Criteria: Neurodegenerative disease non-stroke dizziness cardiopulmonary insufficiency polyneuropathy peripheral vascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Teuschl, Ass.-Prof.
Organizational Affiliation
Donauuniversität Krems (Danube University)
Official's Role
Study Chair
Facility Information:
Facility Name
RehaClinic Kilchberg
City
Kilchberg
State/Province
Zurich
ZIP/Postal Code
8802
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.rehaclinic.ch
Description
RehaClinic AG

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Balance Training After Stroke - a Randomized, Controled Pilot Study

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