Effects of Training Rhythmic and Discrete Aiming Movements on Arm Control and Functionality After Stroke

Stroke Clinical Trial

Official title:

Effects of Training Rhythmic and Discrete Aiming Movements on the Upper Limb Control and Functionality After Stroke: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02765152
• Other study ID #: Universidade Cidade Sao Paulo
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2016
• Last updated: January 27, 2017
• Start date: June 2016
• Est. completion date: September 2018

Study information

• Verified date: January 2017
• Source: Universidade Cidade de Sao Paulo
• Contact: Sandra R Alouche, PhD
• Phone: +551121781565
• Email: sandra.alouche[@]unicid.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Seventy-five patients will be randomized into three groups to receive conventional therapy, consisting of a combination of mobility exercises joint, muscle stretching, strength training, motor coordination exercises, unilateral and bilateral motor tasks as well as oriented tasks training upper limb with a focus on functional tasks. The other groups will receive additional intervention consisting of aiming movement practice according two different protocols: discrete movements to targets placed in different directions and distances; and rhythmic movements also to targets placed in different directions and distances. Both additional interventional interventions will be conducted for 30 minutes over a 5 week-period (total: 10 sessions).

Clinical outcomes (motor control), functional and kinematic will be collected at baseline and at five weeks. Functional results will be collected at the beginning, after 5 weeks and 3 months after randomization. Data will be collected by a blinded assessor on patients' allocation group. All statistical analyzes will be carried out following the principles of intention to treat analysis and differences between groups will be performed using linear mixed models.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria:patients who participate in the survey, adult stroke survivors (>18 years), with primary diagnosis of first-ever unilateral stroke (ischaemic or haemorrhagic), stroke experienced > 6 months prior to study enrollment and score = 20 on the Folstein Mini Mental Status Examination.

Exclusion criteria: patients with excessive pain in the paretic hand, arm or shoulder excessive spasticity at the paretic elbow and wrist as defined as a score of 4 on the Modified Ashworth Spasticity Scale and upper limb comorbidities that could limit their functional recovery (e.g., arthritis, pain, other neurological disorders).

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Conventional Physical Therapy
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)
• 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 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.
• Rhythmic 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.

Locations

Country	Name	City	State
Brazil	Universidade Cidade de Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (18)

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. — View Citation

Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. — View Citation

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. Review. — View Citation

Cauraugh JH, Summers JJ. Neural plasticity and bilateral movements: A rehabilitation approach for chronic stroke. Prog Neurobiol. 2005 Apr;75(5):309-20. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Fugl-Meyer AR, Jääskö 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. — View Citation

Harris JE, Eng JJ. Paretic upper-limb strength best explains arm activity in people with stroke. Phys Ther. 2007 Jan;87(1):88-97. — View Citation

Liepert J. Evidence-based therapies for upper extremity dysfunction. Curr Opin Neurol. 2010 Dec;23(6):678-82. doi: 10.1097/WCO.0b013e32833ff4c4. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. English, French. — View Citation

Ribeiro Coqueiro P, de Freitas SM, Assunção 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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2015;10:CD004433. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	kinematics assessment	Functional capacity: It will be used an experimental apparatus that analyzes the motor behavior the aiming movement (Ribeiro et al., 2014). They will evaluate the movement time (measured in milliseconds), reaction time (in milliseconds) and smoothness (expressed in units of motion). The movement time is the time interval between the beginning and the end of the movement. Reaction time is defined as the time between the start of the imperative stimulus to the beginning of the movement. The smoothness is evaluated by computing the number of times the acceleration zero crossing (positive to negative and vice versa). The resultant variable error (in centimeters) is a measure of variability for both the medial-lateral direction as anteroposterior, assessing the accuracy to hit the target.	Five weeks after randomization
Other	Grip strength	Body function and structure: it will measure the strength of grip and pinch through dynamometer. The results will be presented in kilogram-force (Kgf) (Mathiowetz et al., 1985)	Five weeks after randomization
Other	Modified Ashworth Spasticity Scale	Body function and structure: they will be assessed flexors elbow, wrist and fingers, and forearm pronators. A measurement scale from 0 to 4 points, with 0 representing normal muscle tone and 4 is the highest possible degree of spasticity (Bohannon and Smith, 1987)	Five weeks after randomization
Primary	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	Motor Activity Log (MAL)	Arm function: individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 30 daily functional tasks (original MAL) (Uswatte et al., 2005).; Items scored on a 6-point ordinal scale, where 0 corresponds to the weaker arm was not sued at all for that activity (never). Patients with a score 5 show the ability to use the weaker arm for that activity was as good as before the stroke (normal).	Five weeks and 3 months after randomization
Secondary	Fugl-Meyer Assessment Scale	Motor control: this scale assesses sensorimotor function of upper limb, with score 0-66 points with scores 0-66 points for motor function and 0-126 points for sensory-motor function (Fugl-Meyer, 1975). A higher score is better motor function.	Five weeks after randomization