Rehabilitation of allocentric negelct: A randomised clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00023968

Enrollment

Registered

2021-02-01

Start date

2021-02-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R29.5

Interventions

Group 1: Neglect therapy & functional electrical stimulation: Patients receive neglect therapy for 45 minutes daily for 3 weeks in combination with functional electrical stimulation. The exercises i

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: - Minimum age 18 years - Left-sided allocentric neglect after right hemisphere cerebrovascular lesion - Sufficient resilience for at least 30 minutes - Regular mobilization ability in at least 80 percent of the planned therapies

Exclusion criteria

Exclusion criteria: Exclusion criteria: - Known dementia disease - Normal pressure hydrocephalus - Therapeutic mobilization ability for less than 80% of the planned therapy sessions

Design outcomes

Primary

Measure	Time frame
According to previous case number calculations, at least 12 patients from the Klinik für Neurologie (Klinikum Bremen Ost, KBO) should be included in the study. Primary outcome parameters 1) Apple's Cancellation task (an improvement in Apple's test is defined as the primary outcome parameter, which is defined by a reduction in the number of incorrectly ticked half-open / left-open apples and a decrease in the target stimuli that were omitted) 2) Assessment of everyday relevance: In order to measure difficulties in everyday life, the hospital staff evaluates the patient's care effort on a weekly basis using the "Functional Independence Measure" and the "Early Rehabilitation Barthel Index" To answer the question whether treatment with neglect therapy and FES is more effective than general neuropsychological therapy and FES in neglect patients with allocentric characteristics, the patients from the two intervention groups are examined three days before the start of therapy and once immediately before the start of therapy (T1, T2). The first diagnosis serves to prevent retest effects. This is followed by a 45-minute therapy unit every weekday over a period of three weeks. After a subsequent first postdiagnosis (T3), there is another three-week therapy unit (45 minutes each workday). Following the last therapy unit of the second intervention, the last post-diagnosis (T4) takes place.	—

Measure

Time frame

According to previous case number calculations, at least 12 patients from the Klinik für Neurologie (Klinikum Bremen Ost, KBO) should be included in the study. Primary outcome parameters 1) Apple's Cancellation task (an improvement in Apple's test is defined as the primary outcome parameter, which is defined by a reduction in the number of incorrectly ticked half-open / left-open apples and a decrease in the target stimuli that were omitted) 2) Assessment of everyday relevance: In order to measure difficulties in everyday life, the hospital staff evaluates the patient's care effort on a weekly basis using the "Functional Independence Measure" and the "Early Rehabilitation Barthel Index" To answer the question whether treatment with neglect therapy and FES is more effective than general neuropsychological therapy and FES in neglect patients with allocentric characteristics, the patients from the two intervention groups are examined three days before the start of therapy and once immediately before the start of therapy (T1, T2). The first diagnosis serves to prevent retest effects. This is followed by a 45-minute therapy unit every weekday over a period of three weeks. After a subsequent first postdiagnosis (T3), there is another three-week therapy unit (45 minutes each workday). Following the last therapy unit of the second intervention, the last post-diagnosis (T4) takes place.

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Secondary

Measure	Time frame
Secondary outcome parameters 3) Line bisection: The line bisecting test includes three staggered 21 cm horizontal lines. Their positions are intended to prevent a perceptual grouping process. The patient's job is to mark the center of each line. The distance between the subjective and the real center of the lines is measured. 4) Watch test: The watch test is part of the “Behavioral Inattention Test” and records object-based symptoms of neglect. In an empty circle on an A4 sheet of paper, the patient must draw the numbers on a clock in the circle (0 = normal, 1 = deviations, 2 = complete omission of the left side). 5) Reading performance: Four different continuous texts are used for reading, which are identical in word length. They are presented in a randomized sequence in order to avoid influences resulting from knowledge of the text. The number of words left out (on the left) is counted. 6) Oculography The recording and evaluation of the video-oculographic data takes place with the mobile vestibular analysis system "NysStar I" from Hörniß using the software "Disoft II" To answer the question whether treatment with neglect therapy and FES is more effective than general neuropsychological therapy and FES in neglect patients with allocentric characteristics, the patients from the two intervention groups are examined three days before the start of therapy and once immediately before the start of therapy (T1, T2). The first diagnosis serves to prevent retest effects. This is followed by a 45-minute therapy unit every weekday over a period of three weeks. After a subsequent first postdiagnosis (T3), there is another three-week therapy unit (45 minutes each workday). Following the last therapy unit of the second intervention, the last post-diagnosis (T4) takes place.	—

Measure

Time frame

Secondary outcome parameters 3) Line bisection: The line bisecting test includes three staggered 21 cm horizontal lines. Their positions are intended to prevent a perceptual grouping process. The patient's job is to mark the center of each line. The distance between the subjective and the real center of the lines is measured. 4) Watch test: The watch test is part of the “Behavioral Inattention Test” and records object-based symptoms of neglect. In an empty circle on an A4 sheet of paper, the patient must draw the numbers on a clock in the circle (0 = normal, 1 = deviations, 2 = complete omission of the left side). 5) Reading performance: Four different continuous texts are used for reading, which are identical in word length. They are presented in a randomized sequence in order to avoid influences resulting from knowledge of the text. The number of words left out (on the left) is counted. 6) Oculography The recording and evaluation of the video-oculographic data takes place with the mobile vestibular analysis system "NysStar I" from Hörniß using the software "Disoft II" To answer the question whether treatment with neglect therapy and FES is more effective than general neuropsychological therapy and FES in neglect patients with allocentric characteristics, the patients from the two intervention groups are examined three days before the start of therapy and once immediately before the start of therapy (T1, T2). The first diagnosis serves to prevent retest effects. This is followed by a 45-minute therapy unit every weekday over a period of three weeks. After a subsequent first postdiagnosis (T3), there is another three-week therapy unit (45 minutes each workday). Following the last therapy unit of the second intervention, the last post-diagnosis (T4) takes place.

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Countries

Germany

Contacts

Public ContactHelmut Hildebrandt

Zentrum für Neurologie, Klinikum Bremen-Ost

Helmut.Hildebrandt@klinikum-bremen-ost.de00494214081599

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026