Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients

Chronic Stroke Clinical Trial

Official title:

Intensive Neurorehabilitation and Stimulation in Chronic Stroke Patients With Severe Motor Impairment of the Upper Extremity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03947645
• Other study ID #: In-Tens
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2021
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic stroke patients (> 6 months) with severe motor impairment of the upper extremity will be enrolled in this single-centre, randomized controlled clinical trial (RCT). All patients will take part in two blocks of high-intense motor training with concurrent neuromuscular stimulation of the paretic upper extremity. In a randomized, cross-over block design, patients will receive transcranial stimulation of either the ipsi- or contralesional hemisphere.

Description:

Chronic stroke patients (> 6 months) with severe motor impairment of the upper extremity and non-proportional recovery will be enrolled in this single-centre, randomized controlled clinical trial (RCT). All patients will take part in two blocks of high-intense motor training with concurrent neuromuscular stimulation of the paretic upper extremity. In a randomized, cross-over block design, patients will receive transcranial stimulation of either the ipsi- or contralesional hemisphere.

The primary outcome measure is the Fugl-Meyer Assessment for upper extremity (FM-UE), acquired at baseline, after the intervention period, and at 3 months follow-up. Secondary outcome measures consist of further clinical parameters and biomarkers of corticospinal connectivity.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Written informed consent

• Chronic stage of stroke (> 6 months)

• No active finger extension/hand opening of the paretic side

Exclusion Criteria:

• Pregnancy

• Epilepsy

• Metal implants

• Pacemaker

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

Device:
• Ipsilesional stimulation
Device: ipsilesional transcranial stimulation, neuromuscular Stimulation over target muscle
• Contralesional stimulation
Device: contralesional transcranial stimulation, neuromuscular stimulation over target muscle

Locations

Country	Name	City	State
Germany	University Hospital Tübingen	Tübingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Elektroencephalography in resting and active states		change from baseline to both directly after intervention and 3 months after
Other	Input-Output curves and motor maps with transcranial magnetic stimulation		change from baseline to both directly after intervention and 3 months after
Other	Task-related and evoked electromyography		change from baseline to both directly after intervention and 3 months after
Other	Camera and marker-based motion capturing		change from baseline to both directly after intervention and 3 months after
Primary	Fugl-Meyer Assessment (Upper Extremity)		change from baseline to both directly after intervention and 3 months after
Secondary	Action Research Arm Test (ARAT)	Motor Impairment of the upper extremity. Several objects in different sizes and weights should be moved by patients.	change from baseline to both directly after intervention and 3 months after
Secondary	Arm-A	Questionnaire on capability to care for the paretic arm in different situations of daily living. Scale ranges from 0 (no problems) to 4 (impossible to do).	change from baseline to both directly after intervention and 3 months after
Secondary	Modified Ashworth Scale (MAS)	Spasticity in different body parts. Scale ranges from 0 (no spasticity) to 4 (rigid).	change from baseline to both directly after intervention and 3 months after
Secondary	Fugl-Meyer Assessment (Lower Extremity)	Assessment of motor impairment of the lower extremity.	change from baseline to both directly after intervention and 3 months after
Secondary	10m walking test	Assessment of motor impairment of the lower extremity.	change from baseline to both directly after intervention and 3 months after
Secondary	National Institute of Stroke Scale (NIHSS)	Assessment of severity of stroke and neurological deficits. Scale ranges from 0 (normal) to 2, 3 or 4 (depending on the item).	baseline
Secondary	Modified Rankin Scale (mRS)	Degree of disability after stroke on a scale from 0 (no symptoms) to 6 (dead).	change from baseline to both directly after intervention and 3 months after
Secondary	EQ-5D	Questionnaire on subjective health status. Patients should rate their health status for that day in different tasks of daily living on a scale from no problems, minor problems, moderate problems, big problems to not possible at all.	change from baseline to both directly after intervention and 3 months after
Secondary	CAHAI-13	Test on activities of daily living. Patients should perform several tasks and are scored from 1 (total assist) to 7 (complete independence).	change from baseline to both directly after intervention and 3 months after
Secondary	Stroke Impact Scale	Questionnaire on subjective impact of stroke on daily living and health status. Scale ranges from 1 (most negative answer) to 5 (most positive answer).	change from baseline to both directly after intervention and 3 months after
Secondary	Barthel Index	Questionnaire on extent to which patients can perform activities of daily living on their own. Patients can reach 0 (cannot perform any task) to a maximum of 100 points (can do everything on their own).	change from baseline to both directly after intervention and 3 months after
Secondary	Hospital Anxiety and Depression Scale	Questionnaire on anxiety and depression. Scale ranges from 0 (most positive answer) to 3 (most negative answer).	change from baseline to both directly after intervention and 3 months after
Secondary	Neurological Fatigue Index	Questionnaire on fatigue in the last two weeks. Scale ranges from no agreement at all, no agreement, agreement to some extent to full agreement.	change from baseline to both directly after intervention and 3 months after
Secondary	NEO-Fünf-Faktoren Inventar	Personality questionnaire with 60 statements that patients should rate ranging from strong disagreement, disagreement, neutral, agreement to strong agreement.	baseline
Secondary	Situational Motivation Scale	Questionnaire on motivation to participate in training. Scale ranges from 0 (not correct at all) to 6 (strongly agree).	change from baseline to both directly after intervention and 3 months after
Secondary	Berlin Social Support Scale	Questionnaire to evaluate social support. Patients should rate different questions regarding their most important attachment figure ranging from no agreement at all, no agreement, agreement to some extent to full agreement.	change from baseline to both directly after intervention and 3 months after
Secondary	Credibility/Expectancy Questionnaire	Questionnaire to evaluate expectancies on current program. Scale rangs from 0 (most negative) to 9 (most positive).	change from baseline to both directly after intervention and 3 months after