Balance Training After Stroke - a Randomized, Controled Pilot Study

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT03791671
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-28
• Study First Posted: 2019-01-03
• Study Start: 2019-03-04
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of the walking speed at three weeks	Measurement one day before and one day after the three weeks intervention time, Data analysis through study completion	10m walking test

Secondary Outcome Measures

Name	Time	Method
Change of the balance score at three weeks	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.
Change of the Walking ability (walking aid) at three weeks	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).

Trial Locations

Locations (1)

RehaClinic Kilchberg; 🇨🇭 Kilchberg, Zurich, Switzerland