- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02364141
Trunk Restraint Therapy in Post-stroke Patients.
Trunk Restraint Therapy: the Continuous Use of the Harness Could Promote Feedback Dependence in Post-stroke Patients. A Randomized Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Twenty stroke subjects were recruited from the Physiotherapy and Occupational Therapy Outpatient Unit of the University Hospital at Campinas - UNICAMP and all of them signed informed consent forms previously approved by the Research Ethics Committee of the University (#110/2004). Ten healthy subjects were also selected to obtain normal reference parameters of kinematic assessment. Patients had sustained a single and chronic (>6 months post-event) unilateral stroke of non-traumatic origin, with hemiparetic sequel in the upper limb, could understand simple instructions, perform community gait, and had a good sitting balance. Those with shoulder pain or other neurological and orthopedic conditions affecting the reaching movement ability or trunk, hemispatial neglect or apraxia were excluded. The patients who met the inclusion criteria were stratified to one of two groups. A sealed opaque envelope containing a single cheat of paper marked with numbers 1 (group 1) or 2 (group 2), was used to allocate the patient. This procedure was made by an external assessor. The patients were not informed about the different treatment groups and therefore, they were blind for the type of intervention applied.
The muscle tone (shoulder and elbow flexors) was evaluated using the Modified Ashworth Scale (MAS)9; motor impairment was evaluated using the upper limb section of Fugl-Meyer Assessment Scale (FM) and activities of daily living was assessed by the Barthel Index (BI). Kinematic data were recorded by an infrared system of motion analysis (Qualisys Motion Capture System - 2.57 Sweden) with sample frequency of 240 Hz, during 8 seconds. The coordinated data was low-pass filtered using a 6 Hz, finite impulse response filter with order 26 using the Matlab software. Five infrared reflexive markers were used. For the kinematic capture, the subjects were seated in a chair and invited to fit a cone in a target placed within arm's length (measured on the non-affected arm from the medial border of axilla to the distal wrist crease). The target was placed so that only the arm movement was required to reach the target. The initial hand position of the affected arm was on the lateral trunk, with the shoulder in neutral position and the elbow close to the side of the body (90°). Three trials of 6 to 8 seconds' time were recorded and a media was used to calculate the evaluated data.From the collected dates, values concerning to sagittal (YZ), horizontal (XY) and 3-dimensional (XYZ) planes were computed.
Trunk displacement was verified in millimeters as sagittal movement of marker 3.
Index of curvature was measured from marker 5. This index shows the straightness of the wrist trajectory from the initial position to the goal, resulting in a ratio of actual end point path to a straight line (index = 1, whereas a semicircle has an index of 1.57).
Shoulder angles were calculated using 2 vectors formed from marker 1 to marker 2, and from marker 2 to marker 4; with flexion/extension movements in sagittal plane and adduction/abduction movement in horizontal plane. Full horizontal abduction and the anatomical position were considered at 0°. Flexion/extension elbow angles were measured using 2 vectors formed from marker 2 to 4 and from marker 4 to 5, using the sagittal and horizontal planes. The elbow full extension was considered at 180°.
Movement time was defined as differences between movement onsets and offsets which tangential velocity rose above and fell below at 5% of its peak value.
The maximum tangential velocity of the arm was computed from the velocity vector expressed by a numerical differentiation from wrist and sternum markers in the 3-dimensional plane. Numbers of peaks and the percentage of movement time at the maximum peak velocity (rate - %) were extracted from tangential velocity traces.
The evaluations were performed by a blind researcher, in admission time (PRE), after the end of the twenty treatment sessions (POST) and three months after the training was completed (retention test - RET).
The selected patients were randomized individually into two training groups:
Trunk restraint group - TRG (n = 10): reaching training with trunk restraint by a harness that limited the trunk movements.
Trunk free group - TFG (n = 10): 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 participants will be trained for 10 weeks, and with 3 months of follow-up).
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.
Chi-squared, or Fisher's tests, was used to compare the categorical variables (i.e. gender) between the three groups (HS, TRG, TFG). Mann-Whitney (for two groups) and Kruskal-Wallis (for three groups) tests were used to compare the ratio dates (i.e. age, years since stroke) measured at a single instant. Repeated-measure analysis of variance (ANOVA) and appropriate post-hoc tests (Bonferroni) were applied to compare the numerical variables (i.e. kinematics dates) between groups and instants. The normality of the kinematic variables was detected by Shapiro-Francia test and for variables that were not normal was proposed Box-Cox transformation. The significance level adopted for the statistical tests was 5% (p< 0.05).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trunk restraint therapy
Reaching training with trunk restraint by a harness that limited the trunk movements.
|
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.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
muscle tone (shoulder and elbow flexors)
Time Frame: 10 weeks
|
by Modified Ashworth Scale (MAS)
|
10 weeks
|
upper limb motor impairment
Time Frame: 10 weeks
|
by Fugl-Meyer Assessment Scale (FM)
|
10 weeks
|
activities of daily living level
Time Frame: 10 weeks
|
by Barthel Index (BI)
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trunk displacement in millimeters as sagittal movement
Time Frame: 10 weeks
|
Kinematic data
|
10 weeks
|
Index of curvature of wrist trajectory
Time Frame: 10 weeks
|
Kinematic data
|
10 weeks
|
Shoulder and elbow angles
Time Frame: 10 weeks
|
Kinematic data
|
10 weeks
|
Movement time
Time Frame: 10 weeks
|
Kinematic data
|
10 weeks
|
maximum tangential velocity
Time Frame: 10 weeks
|
Kinematic data
|
10 weeks
|
Numbers of peaks
Time Frame: 10 weeks
|
Kinematic data
|
10 weeks
|
maximum peak velocity
Time Frame: 10 weeks
|
Kinematic data
|
10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Guilherme Borges, PhD, University of Campinas, Brazil
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06/61199-5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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