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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03175237
Other study ID # 262.686
Secondary ID
Status Completed
Phase N/A
First received May 20, 2017
Last updated August 7, 2017
Start date May 10, 2014
Est. completion date September 30, 2015

Study information

Verified date August 2017
Source Universidade Federal do Rio Grande do Norte
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the benefits of Mirror Therapy (MT) and motivation in patients with different levels of post-stroke motor impairment with two different therapy protocols. This is a randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke. Participants were randomized into two intervention groups: MT group with motor patterns of movement (MP, n=13) and MT group with specific functional activities (SA, n=14). Motor impairment assessments (Fugl-Meyer Assessment - FMA), motivation (Intrinsic Motivation Inventory) and functionality (Functional Independence Measure - FIM) were performed before and after treatment, and 3 months after the end of sessions (follow-up). In each intervention group,there were patients classified with mild, moderate or severe motor impairment, according to FMA. All participants performed 15 MT sessions, 3 times a week for 50 minutes each session.


Description:

Objective: To evaluate the benefits of Mirror Therapy (MT) and motivation in patients with different levels of post-stroke motor impairment with two different therapy protocols. Methods: This is a randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke. Participants were randomized into two intervention groups: MT group with motor patterns of movement (MP, n=13) and MT group with specific functional activities (SA, n=14). Motor impairment assessments (Fugl-Meyer Assessment - FMA), motivation (IntrinsicMotivationInventory) and functionality (Functional Independence Measure - FIM) were performed before and after treatment, and 3 months after the end of sessions (follow-up). In each intervention group,there were patients classified with mild, moderate or severe motor impairment, according to FMA. All participants performed 15 MT sessions, 3 times a week for 50 minutes each session.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date September 30, 2015
Est. primary completion date August 15, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Inclusion criteria were age over 18 years, clinical diagnosis of chronic and unilateral stroke (greater than six months after injury), hemiparesis sequel in the upper limb, absence of severe cognitive impairment with scores for the Mini Mental State Examination (MMSE) greater than or equal to 24 points for the educated and 14 for uneducated 17 and good sitting balance, qualified with scores between 20 and 40 on the Berg Balance Scale (BBS)

Exclusion Criteria:

- Those with other neurological diseases and associated physical or mental disabilities, stroke trauma, pain and joint contractures in the upper limb that prevented movement and the ones who missed therapy more than 3 times in a row were excluded

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mirror Therapy


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Rio Grande do Norte

Outcome

Type Measure Description Time frame Safety issue
Primary Fugl-Meyer Assessment Scale Sensory and motor Impairment in post-stroke subjects. Severity of motor damage. In this case, use only upper limb session (score 66) baseline, 8 weeks and 3 months (follow-up)
Secondary Mini-mental state examination brief assessment of cognition baseline
Secondary Berg Balance Scale Assessment of the static, dynamic and anticipatory balance baseline
Secondary Intrinsic Motivation Inventory self-report measure of intrinsic motivation baseline, 7 days and 14 days
Secondary Functional Independence of measure Assessment of activities of daily living and social cognition baseline, 8 weeks and 3 months (follow-up)
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