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Norwegian Constraint-Induced (CI) Therapy Multisite Trial (NORCIMT)

U

University Hospital of North Norway

Status and phase

Terminated
Phase 3

Conditions

Cerebrovascular Accident

Treatments

Procedure: Modified CI therapy

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00906477
Helse Nord SAT 544-06

Details and patient eligibility

About

The purpose of this study is to determine whether modified CI therapy treatment is suitable and effective in the early rehabilitation after stroke, and to compare early CI intervention with a later CI intervention group.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Stroke at more than 5 and less than 26 days ago.(Either first stroke or second stroke without detectable arm weakness after the first stroke).
  • Modified ranking scale 0-2 before admission
  • Persistent unilateral arm or hand paresis (Scandinavian Strokes scale (SSS) arm motor function 2-5 or SSS hand motor function 2-4)
  • Able to lift two fingers with the forearm pronated on the table or able to extend the wrist at least 10 degrees from fully flexed position.
  • Able to follow a two step command.
  • Mini Mental State examination score of more than 20 (or more than 16 in combination with expressive aphasia)

Exclusion criteria

  • Modified Rankin Scale > 4
  • Unable to give informed consent
  • Large hemispatial neglect (more than two cm on the Line Bisection Test)
  • Not expected to survive one year due to other illnesses (eg cardiac, malignancy)
  • Injury or condition in the affected upper extremity that limited use prior to the stroke.
  • Other neurological condition affecting motor function

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

47 participants in 2 patient groups

Early intervention
Experimental group
Description:
Modified CI therapy starting between 7 and 28 days post stroke.
Treatment:
Procedure: Modified CI therapy
Delayed intervention
Active Comparator group
Description:
Modified CI Therapy starting 6 months post stroke
Treatment:
Procedure: Modified CI therapy

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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