NCT03957421

Brief Summary

To determine the impact of underwater vs. land based exercise and/or gait training on functional mobility for patients with stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2020

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

May 14, 2019

Last Update Submit

October 18, 2023

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Dynamic Gait Index

    8 item gait and balance measure looking at fall risk. participants are scored on a 0-3 scale. 19/24 indicates fall risk.

    12 weeks

Secondary Outcomes (5)

  • Romberg

    12 weeks.

  • Sharpened Romberg

    12 weeks

  • Single limb stance

    12 weeks

  • 4-square step test

    12 weeks

  • Timed Up and Go

    12 weeks.

Study Arms (1)

Aquatic exercise is more beneficial than land based exercise

EXPERIMENTAL

use of aquatic exercise will be evaluated for individuals with stroke

Other: aquatic exercise, land based exercise

Interventions

aquatic exercise, land based exerciseOTHER

general warm up and cool down. general exercises and treadmill training at self-selected intensity.

Aquatic exercise is more beneficial than land based exercise

Eligibility Criteria

AgeUp to 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke
  • Able to walk 20 meters without a lower extremity orthotic.

You may not qualify if:

  • Significant fear of water
  • Seizures
  • Incontinence with bowel or bladder
  • Open wounds
  • Infections such as UTI or fever
  • Tracheostomy, nasogastric or gastronomy tube
  • Colostomy
  • Uncontrolled hypertension
  • Skin rash
  • Hard cast due to fracture
  • Isolation precautions
  • IV or indwelling catheters
  • Uncontrolled agitation
  • Require use of continuous supplemental oxygen
  • Allergies to chemicals used in a pool

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Universtiy

Fayetteville, North Carolina, 28311, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physical Therapy

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 21, 2019

Study Start

January 11, 2019

Primary Completion

January 11, 2020

Study Completion

January 11, 2020

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)