Balance Training After Stroke - a Randomized, Controled Pilot Study

NCT ID: NCT03791671

Last Updated: 2019-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-04

Study Completion Date

2019-05-31

Brief Summary

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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

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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.

Conditions

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Stroke

Keywords

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Balance training Gait Speed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

individual balance training

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

group balance training

Intervention Type OTHER

Like the individual balance training

Interventions

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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.

Intervention Type OTHER

group balance training

Like the individual balance training

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RehaClinic AG

OTHER

Sponsor Role lead

Responsible Party

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Mrs. Wiebke Weigert

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yvonne Teuschl, Ass.-Prof.

Role: STUDY_CHAIR

Donauuniversität Krems (Danube University)

Locations

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RehaClinic Kilchberg

Kilchberg, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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2018-01700

Identifier Type: -

Identifier Source: org_study_id