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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02118506
Other study ID # CEP/UFRN 275.155
Secondary ID
Status Completed
Phase N/A
First received January 20, 2014
Last updated April 16, 2014
Start date December 2012
Est. completion date September 2013

Study information

Verified date April 2014
Source Universidade Federal do Rio Grande do Norte
Contact n/a
Is FDA regulated No
Health authority Brazil: Associação Fundo de Incentivo à Pesquisa
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of mental practice, associated with physical practice, on gait (cinematic parameters and mobility) in individuals with idiopathic Parkinson's disease. It is believed that familiarity with the normal gait pattern, associated with mental practice and physical practice can trigger significant changes in spatiotemporal and angular parameters that are not observed in the group not submitted to mental practice.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 44 Years to 75 Years
Eligibility Inclusion Criteria:

- the subjects should be in use of antiparkinsonian medication,

- be between stages 2 and 3 of the Hoehn and Yahr modified scale);

- walk without any brace or aid device, independently (scores between 3 and 5 of the Functional Ambulatory Category - FAC) for at least 10 meters

- were not undergoing stereotactic surgery.

Exclusion Criteria:

- We excluded those who were unable or declined to complete the training protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Physical practice
The control group underwent familiarization of gait phases using cards with gait phases and physical gait training. Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases. Then, they were submitted to a physical gait training. They underwent a single training session during 1 hour and 30 minutes and were reassessed 10 minutes and 1 day after the end of the session, in respect of the kinematic gait and mobility.
Mental and physical practice
The experimental group underwent familiarization of gait phases using cards with gait phases, mental practice of gait and physical gait training. Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases. Then, they were submitted to a mental training of gait. They imagined the gait steps per 400 repetitions. While imagining, they verbalized the gait phases. Finally, they were submitted to a physical gait training. They executed 400 steps. They underwent a single training session during 1 hour and 30 minutes and were reassessed 10 minutes and 1 day after the end of the session, in respect of the kinematic gait and mobility.

Locations

Country Name City State
Brazil Federal University of Rio Grande do Norte Natal Rio Grande do Norte

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Step length at 10 minutes and 1 day Three observetions were done. At baseline, 10 minutes and 1 day after intervention. No
Secondary Change from Baseline in Double Limb Support Time at 10 minutes and 1 day Double Limb Support Time is the period when both feet are on the ground at the same time. The first period of double limb support begins at initial contact, and lasts, in healthy people, 10 to 12 percent of the cycle. The second period of double limb support occurs in the final 10 to 12 percent of stance phase. As the stance limb prepares to leave the ground, the opposite limb contacts the ground and accepts the body's weight. The two periods of double limb support account for 20 to 24 percent of the gait cycle's total duration. In people with Parkinson disease, this period lasts longer. Three observetions were done. At baseline, 10 minutes and 1 day after intervention. No
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