NCT02999971

Brief Summary

The objective of this study is to investigate the relative effectiveness of CCT on water versus on land in stroke patients. Additionally, the study will to determine if there are differences in the results obtained, between two CCT programs in the following parameters: gait, balance and dexterity

Trial Health

100
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable stroke

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

2.9 years

First QC Date

December 18, 2016

Last Update Submit

March 30, 2020

Conditions

Keywords

circuit class therapyICF modelaquatic therapyneuro-rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 10 meters walk test

    60 seconds

Secondary Outcomes (8)

  • Test Up & Go

    5 minutes

  • Berg Balance Scale (BBS)

    20 minutes

  • Romberg Test

    1 minute

  • Fugl-Meyer Assessment

    15 minutes

  • Functional Reach Test (FRT)

    10 minutes

  • +3 more secondary outcomes

Study Arms (2)

circuit class therapy in water

EXPERIMENTAL

CCT on water. The intervention developed in this study will be through the realization of an exercise program in circuit (CCT). One of the groups will receive treatment in the water (intervention group), and the other on land (control group). In both groups, the intervention will be a 7-week class therapy, 3-times weekly, giving a total of 20 sessions.

Other: circuit class therapy in water

circuit class therapy on land

EXPERIMENTAL

CCT on land. The intervention developed in this study will be through the realization of an exercise program in circuit (CCT). One of the groups will receive treatment in the water (intervention group), and the other on land (control group). In both groups, the intervention will be a 7-week class therapy, 3-times weekly, giving a total of 20 sessions.

Other: circuit class therapy on land

Interventions

The circuit, the main part of the session, include a series of 10 different workstations, arranged to progress in complexity, in order to work several segments of the body, oriented towards a functional recovery objective. These stations will be made up of task-specific activities for gait, balance and dexterity. Time in each workstation will be 5 minutes divided as follows: 4 minutes work period and 1 minute rest period, of these, last 30 seconds will be change period for crossing from one workstation to the next. After 50 minutes, each patient will have covered the 10 workstations, thus working in all of the objectives pursued in the realization on this CCT: gait, balance and dexterity.

circuit class therapy in water

The circuit, the main part of the session, include a series of 10 different workstations, arranged to progress in complexity, in order to work several segments of the body, oriented towards a functional recovery objective. These stations will be made up of task-specific activities for gait, balance and dexterity. Time in each workstation will be 5 minutes divided as follows: 4 minutes work period and 1 minute rest period, of these, last 30 seconds will be change period for crossing from one workstation to the next. After 50 minutes, each patient will have covered the 10 workstations, thus working in all of the objectives pursued in the realization on this CCT: gait, balance and dexterity.

circuit class therapy on land

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diagnosis of stroke (ischemic or hemorrhagic) onset ≤ 3 years; with hemiparesis secondary;
  • age ≥18 to ≤ 90;
  • provide a written informed consent;
  • able to walk for at least 10 m without assistance

You may not qualify if:

  • patients with uncontrolled or risky conditions (acute myocardial infarction, arrhythmia, heart failure, uncontrolled hypertension or unstable cardiovascular state);
  • with infectious diseases, ulcers or urinary and / or faecal incontinence;
  • additional neurological and / or orthopedic deficits that alter ambulation;
  • unable to follow treatment (cognitive, visual ...).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Interventions

Water

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

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
Physiotherapy degree

Study Record Dates

First Submitted

December 18, 2016

First Posted

December 21, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share