Effects of Treadmill Gait Training With Loading in Individuals With Stroke

NCT ID: NCT02113098

Last Updated: 2019-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-10-31

Brief Summary

The purpose of this study is to determine whether the add load on non-paretic lower limb of individuals that suffer a stroke, while walking on a treadmill, is effective for restore gait symmetry of these individuals, in a subacute phase of stroke.

Detailed Description

This is a randomized and blinded clinical trial, in which participants are being randomly divided into experimental group and control group, in order to verify the effects of adding load on gait symmetry after stroke. 40 individuals will participate, and the calculation of sample size was performed from the ratio variable symmetry of swing time, based on previous study. Whereas about 15% of individuals could give up to participate in the study during their course (dropout rate), we determined a number of 20 participants in each group.

Conditions

Stroke; Gait Disorders, Neurologic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treadmill, ankle load

The experimental group will perform gait training on a treadmill with added load to the non-paretic lower limb

Group Type: EXPERIMENTAL

Treadmill, ankle load

Intervention Type: OTHER

The experimental group will perform gait training on a treadmill (Gait Trainer 2®) with added load to the ankle of the non-paretic lower limb, plus physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks

Treadmill

The control group (active comparator) will perform gait training on a treadmill

Group Type: ACTIVE_COMPARATOR

Treadmill

Intervention Type: OTHER

The control group (active comparator) will perform gait training on a treadmill (Gait Trainer 2®) with physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks

Interventions

Treadmill, ankle load

The experimental group will perform gait training on a treadmill (Gait Trainer 2®) with added load to the ankle of the non-paretic lower limb, plus physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks

Intervention Type: OTHER

Treadmill

The control group (active comparator) will perform gait training on a treadmill (Gait Trainer 2®) with physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• First episode of stroke (ischemic or hemorrhagic) which determined unilateral hemiparesis
• Time of lesion less one year
• Able to walk independently by 10 feet on flat surface without the use of assistive devices
• Gait speed less than 0.8 m / s
• Ability to understand and obey simple commands

Exclusion Criteria

• Instability of cardiac conditions
• Adverse clinical conditions affecting balance and / or gait
• Pain and / or severe discomfort that impede the realization of the proposed activities
• Decompensation in systemic blood pressure, with the systolic and diastolic values above 200 mmHg and 110 mmHg, respectively, before and / or after training
• Submaximal heart rate above the allowed values during training

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: lead

Responsible Party

Ana Raquel Rodrigues Lindquist, PhD

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tatiana S Ribeiro, MSc

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio Grande do Norte

Locations

Universidade Federal do Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

Countries

Brazil

References

E Silva EMGS, Ribeiro TS, da Silva TCC, Costa MFP, Cavalcanti FADC, Lindquist ARR. Effects of constraint-induced movement therapy for lower limbs on measurements of functional mobility and postural balance in subjects with stroke: a randomized controlled trial. Top Stroke Rehabil. 2017 Dec;24(8):555-561. doi: 10.1080/10749357.2017.1366011. Epub 2017 Aug 31.

Reference Type: DERIVED

PMID: 28859603 (View on PubMed)

Other Identifiers

488.293

Identifier Type: -

Identifier Source: org_study_id