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Trial record 68 of 183 for:    RET

Trunk Restraint Therapy in Post-stroke Patients.

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ClinicalTrials.gov Identifier: NCT02364141
Recruitment Status : Completed
First Posted : February 16, 2015
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
Roberta de Oliveira Cacho, University of Campinas, Brazil

Brief Summary:
The aim of this study was to evaluate the long-term effects of the task-specific training with trunk restraint comparing to the free one in post-stroke reaching movements. Twenty hemiparetic chronic stroke patients were selected and randomized into two training groups: Trunk restraint group - TRG (reaching training with trunk restraint) and Trunk free group - TFG (unrestraint reaching). Twenty sessions with forty-five minutes of training were accomplished. The subjects were evaluated in pre-treatment (PRE), post-treatment (POST) and three months after the completed training (RET). The measures administered were the Modified Ashworth Scale, Barthel Index, Fugl-Meyer Scale and kinematic analysis (movement trajectory, velocity, angles).

Condition or disease Intervention/treatment Phase
Stroke Other: Trunk restraint therapy Other: Trunk unrestraint therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Trunk Restraint Therapy: the Continuous Use of the Harness Could Promote Feedback Dependence in Post-stroke Patients. A Randomized Trial.
Study Start Date : August 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : July 2008

Arm Intervention/treatment
Experimental: Trunk restraint therapy
Reaching training with trunk restraint by a harness that limited the trunk movements.
Other: Trunk restraint therapy

Reaching training with trunk restraint by a harness that limited the trunk movements.

Forty-five training minutes, twice a week, totaling twenty sessions, were performed. The training was based in the motor learning concepts including repetitive and task-specific practice. The training task consisted of grasping a cone (3.5 cm diameter base, 13 cm high) and fitting random targets as requested by the therapist in a training platform (54 cm length, 64 cm extent, 1.5 cm high) with 9 targets (6.5 cm diameter) placed 10-13 cm apart, along 3 lines. The targets that were ordered in a way that stimulated the complete range of motion of shoulder and elbow, had pictures, colors, letters and numbers on them yielding variability and feedback to the performing tasks.


Active Comparator: Trunk unrestraint therapy
Unrestraint reaching training, only with verbal feedback to maintain the trunk right position.
Other: Trunk unrestraint therapy

Unrestraint reaching training, only with verbal feedback to maintain the trunk right position.

Forty-five training minutes, twice a week, totaling twenty sessions, were performed. The training was based in the motor learning concepts including repetitive and task-specific practice. The training task consisted of grasping a cone (3.5 cm diameter base, 13 cm high) and fitting random targets as requested by the therapist in a training platform (54 cm length, 64 cm extent, 1.5 cm high) with 9 targets (6.5 cm diameter) placed 10-13 cm apart, along 3 lines. The targets that were ordered in a way that stimulated the complete range of motion of shoulder and elbow, had pictures, colors, letters and numbers on them yielding variability and feedback to the performing tasks





Primary Outcome Measures :
  1. muscle tone (shoulder and elbow flexors) [ Time Frame: 10 weeks ]
    by Modified Ashworth Scale (MAS)

  2. upper limb motor impairment [ Time Frame: 10 weeks ]
    by Fugl-Meyer Assessment Scale (FM)

  3. activities of daily living level [ Time Frame: 10 weeks ]
    by Barthel Index (BI)


Secondary Outcome Measures :
  1. Trunk displacement in millimeters as sagittal movement [ Time Frame: 10 weeks ]
    Kinematic data

  2. Index of curvature of wrist trajectory [ Time Frame: 10 weeks ]
    Kinematic data

  3. Shoulder and elbow angles [ Time Frame: 10 weeks ]
    Kinematic data

  4. Movement time [ Time Frame: 10 weeks ]
    Kinematic data

  5. maximum tangential velocity [ Time Frame: 10 weeks ]
    Kinematic data

  6. Numbers of peaks [ Time Frame: 10 weeks ]
    Kinematic data

  7. maximum peak velocity [ Time Frame: 10 weeks ]
    Kinematic data



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • single and chronic (>6 months post-event) unilateral stroke of non-traumatic origin
  • hemiparetic sequel in the upper limb
  • could understand simple instructions
  • perform community gait
  • had a good sitting balance

Exclusion Criteria:

  • shoulder pain or other neurological and orthopedic conditions affecting the reaching movement ability or trunk
  • hemispatial neglect
  • apraxia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364141


Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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Study Director: Guilherme Borges, PhD University of Campinas, Brazil

Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Roberta de Oliveira Cacho, PhD, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02364141     History of Changes
Other Study ID Numbers: 06/61199-5
First Posted: February 16, 2015    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015
Keywords provided by Roberta de Oliveira Cacho, University of Campinas, Brazil:
stroke
upper extremity
motor learning
rehabilitation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases