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NCT Number: NCT03791671

Balance Training After Stroke - a Randomized, Controled Pilot Study

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RehaClinic Kilchberg

Kilchberg, Canton of Zurich, 8802, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

individual balance training

Other

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.

group balance training

Other

Like the individual balance training

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

RehaClinic AG

Other

Registry information

Official study title

Individual Balance Training vs. Group Balance Training to Improve Walking Speed Post Stroke - a Randomized, Controled Pilot Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 3, 2019
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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