Trunk Restraint Therapy in Post-stroke Patients.

NCT02364141 | Completed DMC

• 1 other identifier: 06/61199-5
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Stroke

Keywords

stroke; upper extremity; motor learning; rehabilitation

Outcome Measures

Primary Outcomes (3)

• muscle tone (shoulder and elbow flexors)

  by Modified Ashworth Scale (MAS)

  10 weeks

• upper limb motor impairment

  by Fugl-Meyer Assessment Scale (FM)

  10 weeks

• activities of daily living level

  by Barthel Index (BI)

  10 weeks

Secondary Outcomes (7)

• Trunk displacement in millimeters as sagittal movement

  10 weeks

• Index of curvature of wrist trajectory

  10 weeks

• Shoulder and elbow angles

  10 weeks

• Movement time

  10 weeks

• maximum tangential velocity

  10 weeks

Study Arms (2)

Trunk restraint therapy

EXPERIMENTAL

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

Other: Trunk restraint therapy

Trunk unrestraint therapy

ACTIVE COMPARATOR

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

Other: Trunk unrestraint therapy

Interventions

Trunk restraint therapy OTHER

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.

Trunk restraint therapy

Trunk unrestraint therapy OTHER

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

Trunk unrestraint therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Related Publications (10)

• Cirstea MC, Levin MF. Compensatory strategies for reaching in stroke. Brain. 2000 May;123 ( Pt 5):940-53. doi: 10.1093/brain/123.5.940.

  PMID: 10775539 BACKGROUND

• Archambault P, Pigeon P, Feldman AG, Levin MF. Recruitment and sequencing of different degrees of freedom during pointing movements involving the trunk in healthy and hemiparetic subjects. Exp Brain Res. 1999 May;126(1):55-67. doi: 10.1007/s002210050716.

  PMID: 10333007 BACKGROUND

• Michaelsen SM, Levin MF. Short-term effects of practice with trunk restraint on reaching movements in patients with chronic stroke: a controlled trial. Stroke. 2004 Aug;35(8):1914-9. doi: 10.1161/01.STR.0000132569.33572.75. Epub 2004 Jun 10.

  PMID: 15192250 BACKGROUND

• Michaelsen SM, Luta A, Roby-Brami A, Levin MF. Effect of trunk restraint on the recovery of reaching movements in hemiparetic patients. Stroke. 2001 Aug;32(8):1875-83. doi: 10.1161/01.str.32.8.1875.

  PMID: 11486120 BACKGROUND

• Michaelsen SM, Dannenbaum R, Levin MF. Task-specific training with trunk restraint on arm recovery in stroke: randomized control trial. Stroke. 2006 Jan;37(1):186-92. doi: 10.1161/01.STR.0000196940.20446.c9. Epub 2005 Dec 8.

  PMID: 16339469 BACKGROUND

• Woodbury ML, Howland DR, McGuirk TE, Davis SB, Senesac CR, Kautz S, Richards LG. Effects of trunk restraint combined with intensive task practice on poststroke upper extremity reach and function: a pilot study. Neurorehabil Neural Repair. 2009 Jan;23(1):78-91. doi: 10.1177/1545968308318836. Epub 2008 Sep 23.

  PMID: 18812433 BACKGROUND

• Wu CY, Chen YA, Chen HC, Lin KC, Yeh IL. Pilot trial of distributed constraint-induced therapy with trunk restraint to improve poststroke reach to grasp and trunk kinematics. Neurorehabil Neural Repair. 2012 Mar-Apr;26(3):247-55. doi: 10.1177/1545968311415862. Epub 2011 Sep 8.

  PMID: 21903975 BACKGROUND

• Stewart JC, Gordon J, Winstein CJ. Control of reach extent with the paretic and nonparetic arms after unilateral sensorimotor stroke: kinematic differences based on side of brain damage. Exp Brain Res. 2014 Jul;232(7):2407-19. doi: 10.1007/s00221-014-3938-5. Epub 2014 Apr 10.

  PMID: 24718494 BACKGROUND

• de Oliveira R, Cacho EW, Borges G. Improvements in the upper limb of hemiparetic patients after reaching movements training. Int J Rehabil Res. 2007 Mar;30(1):67-70. doi: 10.1097/MRR.0b013e3280143bbf.

  PMID: 17293723 RESULT

• de Oliveira Cacho R, Cacho EWA, Ortolan RL, Cliquet A Jr, Borges G. Trunk restraint therapy: the continuous use of the harness could promote feedback dependence in poststroke patients: a randomized trial. Medicine (Baltimore). 2015 Mar;94(12):e641. doi: 10.1097/MD.0000000000000641.

  PMID: 25816031 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Guilherme Borges, PhD

  University of Campinas, Brazil

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 16, 2015
• Study Start: August 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: July 1, 2008
• Last Updated: February 16, 2015

Record last verified: 2015-02