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StrokeNCT02364141

Trunk Restraint Therapy in Post-stroke Patients.

A study testing Trunk restraint therapy and Trunk unrestraint therapy in people with Stroke, run by University of Campinas, Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
Trunk restraint therapy and Trunk unrestraint therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Aug 2004to Jul 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

About this study

Official title: Trunk Restraint Therapy: the Continuous Use of the Harness Could Promote Feedback Dependence in Post-stroke Patients. A Randomized Trial.

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).

Read the 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).

Conditions
Stroke
Being tested
Trunk restraint therapy, Trunk unrestraint therapy
Keywords
stroke, upper extremity, motor learning, rehabilitation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trunk restraint therapyOther

    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 unrestraint therapyOther

    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

Study groups in NCT02364141
Study groupRoleWhat they receive
Trunk restraint therapyExperimentalReaching training with trunk restraint by a harness that limited the trunk movements.
Receives: Other: Trunk restraint therapy
Trunk unrestraint therapyActive comparatorUnrestraint reaching training, only with verbal feedback to maintain the trunk right position.
Receives: Other: Trunk unrestraint therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. muscle tone (shoulder and elbow flexors)

    by Modified Ashworth Scale (MAS)

    Measured: 10 weeks

  2. upper limb motor impairment

    by Fugl-Meyer Assessment Scale (FM)

    Measured: 10 weeks

  3. activities of daily living level

    by Barthel Index (BI)

    Measured: 10 weeks

Secondary outcomes (7)
  1. Trunk displacement in millimeters as sagittal movement

    Kinematic data

    Measured: 10 weeks

  2. Index of curvature of wrist trajectory

    Kinematic data

    Measured: 10 weeks

  3. Shoulder and elbow angles

    Kinematic data

    Measured: 10 weeks

  4. Movement time

    Kinematic data

    Measured: 10 weeks

  5. maximum tangential velocity

    Kinematic data

    Measured: 10 weeks

  6. Numbers of peaks

    Kinematic data

    Measured: 10 weeks

  7. maximum peak velocity

    Kinematic data

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2015 (estimated)
  2. Study startAug 2004
  3. Primary completionNov 2007
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02364141
Sponsor's protocol ID
06/61199-5
Status last verified
Feb 2015
First submitted
5 Feb 2015
Last updated
16 Feb 2015
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 10775539
  • 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.

    PubMed 10333007
  • 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.

    PubMed 15192250
  • 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.

    PubMed 11486120
  • 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.

    PubMed 16339469
  • 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.

    PubMed 18812433
  • 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.

    PubMed 21903975
  • 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.

    PubMed 24718494
  • 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.

    PubMed 17293723
  • 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.

    PubMed 25816031

Questions about this trial

What is this clinical trial studying?

A study testing Trunk restraint therapy and Trunk unrestraint therapy in people with Stroke, run by University of Campinas, Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

muscle tone (shoulder and elbow flexors) (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02364141, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.

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Trunk Restraint Therapy in Post-stroke Patients. | AzTrials