NCT02765152

Brief Summary

The purpose of this study is to verify the additional effects of rhythmic specific training, discrete specific training additional to conventional therapy on the upper limb after chronic stroke subjects on the outcomes: motor control and functionality.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

April 19, 2016

Last Update Submit

January 27, 2017

Conditions

Keywords

exerciserhythmic movementdiscrete movement

Outcome Measures

Primary Outcomes (1)

  • Stroke Impact Scale (SIS)

    Functionality: questionnaire which evaluates functionality. In this study will be evaluated four areas (arm muscle strength, hand function, activities of daily living and social participation)(Duncan et al., 1999). Each domain is scored from 1 to 5 (1 point corresponds to the worst possible outcome and 5 points to the best result). For the four areas the lowest possible score is 28 points and the highest is 125 points.

    Five weeks after randomization and 3 months after randomization

Secondary Outcomes (2)

  • Motor Activity Log (MAL)

    Five weeks and 3 months after randomization

  • Fugl-Meyer Assessment Scale

    Five weeks after randomization

Other Outcomes (3)

  • kinematics assessment

    Five weeks after randomization

  • Grip strength

    Five weeks after randomization

  • Modified Ashworth Spasticity Scale

    Five weeks after randomization

Study Arms (3)

Conventional Physical Therapy

ACTIVE COMPARATOR

Usual therapy: joint mobility exercises, stimulating joint movement of the main active components of the upper limb; major muscle groups stretching, especially in the affected muscles by tone impairment; manual resistance training according to the degree of the patient's muscle strength, prioritizing the functional specificity of the upper limb, so the majority of the exercises will be held in open chain; motor coordination exercises, unilateral and bilateral motor tasks as well as task-oriented training of the upper limb with a focus on functional tasks.

Other: Conventional Physical Therapy

discrete movement training group

EXPERIMENTAL

Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The starting point of the movement and its target are predetermined. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.

Other: Discrete movement training group

rhythmic movement training group

EXPERIMENTAL

Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The movement begins in a predetermined starting point, directed to a target and returns to the starting point. This activity is performed several times with rhythmic movements. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.

Other: Rhythmic movement training group

Interventions

Combination of joint mobility exercises, specific exercises for muscle strength and motor coordination exercises, unilateral and bilateral motor tasks as well as task-oriented training of the upper limb with a focus on functional tasks. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week)

Conventional Physical Therapy

Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The starting point of the movement and its target are predetermined. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.

discrete movement training group

Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The movement begins in a predetermined starting point, directed to a target and returns to the starting point. This activity is performed several times with rhythmic movements. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.

rhythmic movement training group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Cidade de Sao Paulo

São Paulo, São Paulo, 03071-000, Brazil

RECRUITING

Related Publications (18)

  • Cauraugh JH, Summers JJ. Neural plasticity and bilateral movements: A rehabilitation approach for chronic stroke. Prog Neurobiol. 2005 Apr;75(5):309-20. doi: 10.1016/j.pneurobio.2005.04.001.

    PMID: 15885874BACKGROUND
  • Naghdi S, Ansari NN, Mansouri K, Hasson S. A neurophysiological and clinical study of Brunnstrom recovery stages in the upper limb following stroke. Brain Inj. 2010;24(11):1372-8. doi: 10.3109/02699052.2010.506860.

    PMID: 20715900BACKGROUND
  • Harris JE, Eng JJ. Paretic upper-limb strength best explains arm activity in people with stroke. Phys Ther. 2007 Jan;87(1):88-97. doi: 10.2522/ptj.20060065. Epub 2006 Dec 19.

    PMID: 17179441BACKGROUND
  • Faria-Fortini I, Michaelsen SM, Cassiano JG, Teixeira-Salmela LF. Upper extremity function in stroke subjects: relationships between the international classification of functioning, disability, and health domains. J Hand Ther. 2011 Jul-Sep;24(3):257-64; quiz 265. doi: 10.1016/j.jht.2011.01.002. Epub 2011 Mar 21.

    PMID: 21420279BACKGROUND
  • Sirtori V, Corbetta D, Moja L, Gatti R. Constraint-induced movement therapy for upper extremities in stroke patients. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD004433. doi: 10.1002/14651858.CD004433.pub2.

    PMID: 19821326BACKGROUND
  • Liepert J. Evidence-based therapies for upper extremity dysfunction. Curr Opin Neurol. 2010 Dec;23(6):678-82. doi: 10.1097/WCO.0b013e32833ff4c4.

    PMID: 20852418BACKGROUND
  • Ada L, O'Dwyer N, O'Neill E. Relation between spasticity, weakness and contracture of the elbow flexors and upper limb activity after stroke: an observational study. Disabil Rehabil. 2006 Jul 15-30;28(13-14):891-7. doi: 10.1080/09638280500535165.

    PMID: 16777777BACKGROUND
  • Oujamaa L, Relave I, Froger J, Mottet D, Pelissier JY. Rehabilitation of arm function after stroke. Literature review. Ann Phys Rehabil Med. 2009 Apr;52(3):269-93. doi: 10.1016/j.rehab.2008.10.003. Epub 2009 Apr 9. English, French.

    PMID: 19398398BACKGROUND
  • Cauraugh JH, Lodha N, Naik SK, Summers JJ. Bilateral movement training and stroke motor recovery progress: a structured review and meta-analysis. Hum Mov Sci. 2010 Oct;29(5):853-70. doi: 10.1016/j.humov.2009.09.004. Epub 2009 Nov 18.

    PMID: 19926154BACKGROUND
  • van Delden AE, Peper CE, Beek PJ, Kwakkel G. Unilateral versus bilateral upper limb exercise therapy after stroke: a systematic review. J Rehabil Med. 2012 Feb;44(2):106-17. doi: 10.2340/16501977-0928.

    PMID: 22266762BACKGROUND
  • Chang JJ, Tung WL, Wu WL, Huang MH, Su FC. Effects of robot-aided bilateral force-induced isokinetic arm training combined with conventional rehabilitation on arm motor function in patients with chronic stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1332-8. doi: 10.1016/j.apmr.2007.07.016.

    PMID: 17908578BACKGROUND
  • Smits-Engelsman BC, Swinnen SP, Duysens J. The advantage of cyclic over discrete movements remains evident following changes in load and amplitude. Neurosci Lett. 2006 Mar 20;396(1):28-32. doi: 10.1016/j.neulet.2005.11.001. Epub 2005 Dec 2.

    PMID: 16326008BACKGROUND
  • Duncan PW, Wallace D, Lai SM, Johnson D, Embretson S, Laster LJ. The stroke impact scale version 2.0. Evaluation of reliability, validity, and sensitivity to change. Stroke. 1999 Oct;30(10):2131-40. doi: 10.1161/01.str.30.10.2131.

    PMID: 10512918BACKGROUND
  • Uswatte G, Taub E, Morris D, Vignolo M, McCulloch K. Reliability and validity of the upper-extremity Motor Activity Log-14 for measuring real-world arm use. Stroke. 2005 Nov;36(11):2493-6. doi: 10.1161/01.STR.0000185928.90848.2e. Epub 2005 Oct 13.

    PMID: 16224078BACKGROUND
  • Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.

    PMID: 1135616BACKGROUND
  • Ribeiro Coqueiro P, de Freitas SM, Assuncao e Silva CM, Alouche SR. Effects of direction and index of difficulty on aiming movements after stroke. Behav Neurol. 2014;2014:909182. doi: 10.1155/2014/909182. Epub 2014 Jan 28.

    PMID: 24803738BACKGROUND
  • Mathiowetz V, Kashman N, Volland G, Weber K, Dowe M, Rogers S. Grip and pinch strength: normative data for adults. Arch Phys Med Rehabil. 1985 Feb;66(2):69-74.

    PMID: 3970660BACKGROUND
  • Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

    PMID: 3809245BACKGROUND

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Sandra R Alouche, PhD

    Universidade Cidade São Paulo

    STUDY DIRECTOR

Central Study Contacts

Sandra R Alouche, PhD

CONTACT

Leonardo OP Costa, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 19, 2016

First Posted

May 6, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

September 1, 2018

Last Updated

January 30, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations