NCT03791671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

3 months

First QC Date

December 20, 2018

Last Update Submit

June 27, 2019

Conditions

Keywords

Balance trainingGait Speed

Outcome Measures

Primary Outcomes (1)

  • Change of the walking speed at three weeks

    10m walking test

    Measurement one day before and one day after the three weeks intervention time, Data analysis through study completion

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (2)

individual balance training

EXPERIMENTAL

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

group balance training

ACTIVE COMPARATOR

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

Interventions

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.

individual balance training

Like the individual balance training

group balance training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RehaClinic Kilchberg

Kilchberg, Canton of Zurich, 8802, Switzerland

Location

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yvonne Teuschl, Ass.-Prof.

    Donauuniversität Krems (Danube University)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 20, 2018

First Posted

January 3, 2019

Study Start

March 4, 2019

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

June 28, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations