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Balance Training After Stroke - a Randomized, Controled Pilot Study

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ClinicalTrials.gov Identifier: NCT03791671
Recruitment Status : Completed
First Posted : January 3, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Mrs. Wiebke Weigert, RehaClinic AG

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.

Condition or disease Intervention/treatment Phase
Stroke Other: individual balance training Other: group balance training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Individual Balance Training vs. Group Balance Training to Improve Walking Speed Post Stroke - a Randomized, Controled Pilot Study
Actual Study Start Date : March 4, 2019
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Arm Intervention/treatment
Experimental: individual balance training

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.

Other: individual balance training
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.

Active Comparator: group balance training

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.

Other: group balance training
Like the individual balance training




Primary Outcome Measures :
  1. Change of the walking speed at three weeks [ Time Frame: Measurement one day before and one day after the three weeks intervention time, Data analysis through study completion ]
    10m walking test


Secondary Outcome Measures :
  1. Change of the balance score at three weeks [ Time Frame: Measurement one day before and one day after the three weeks intervention time, Data analysis through study completion ]
    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.

  2. Change of the Walking ability (walking aid) at three weeks [ Time Frame: Measurement one day before and one day after the three weeks intervention time, Data analysis through study completion ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791671


Locations
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Switzerland
RehaClinic Kilchberg
Kilchberg, Zurich, Switzerland, 8802
Sponsors and Collaborators
RehaClinic AG
Investigators
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Study Chair: Yvonne Teuschl, Ass.-Prof. Donauuniversität Krems (Danube University)
  Study Documents (Full-Text)

Documents provided by Mrs. Wiebke Weigert, RehaClinic AG:
Informed Consent Form  [PDF] November 20, 2018


Additional Information:
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Responsible Party: Mrs. Wiebke Weigert, Principal investigator, RehaClinic AG
ClinicalTrials.gov Identifier: NCT03791671     History of Changes
Other Study ID Numbers: 2018-01700
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mrs. Wiebke Weigert, RehaClinic AG:
Balance training
Gait Speed
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases