Trial Outcomes & Findings for Aquatic Treadmill Therapy for Improving Gait, Balance, Fitness and Quality of Life in Stroke Patients (NCT NCT00983827)

NCT ID: NCT00983827

Last Updated: 2013-01-15

Results Overview

Number of procedure related adverse events that occurred during study.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

16 weeks

Results posted on

2013-01-15

Participant Flow

Participant milestones

Participant milestones
Measure
Aquatic Treadmill Training
Aquatic treadmill training (ATT) is a pool-based treadmill training that combines the three concepts of unweighting the body, treadmill training, and the resistance effects of water into one modality.
Overall Study
STARTED
8
Overall Study
COMPLETED
7
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Aquatic Treadmill Training
Aquatic treadmill training (ATT) is a pool-based treadmill training that combines the three concepts of unweighting the body, treadmill training, and the resistance effects of water into one modality.
Overall Study
Withdrawal by Subject
1

Baseline Characteristics

Aquatic Treadmill Therapy for Improving Gait, Balance, Fitness and Quality of Life in Stroke Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Aquatic Treadmill Training
n=8 Participants
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
Age Continuous
53.5 years
STANDARD_DEVIATION 6.48 • n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
Region of Enrollment
United States
8 participants
n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Number of procedure related adverse events that occurred during study.

Outcome measures

Outcome measures
Measure
Aquatic Treadmill Training
n=8 Participants
Safety
0 adverse events

Adverse Events

Aquatic Treadmill Training

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Aquatic Treadmill Training
n=8 participants at risk
General disorders
Sharp Head Pain
12.5%
1/8 • Number of events 1
Injury, poisoning and procedural complications
Fall
12.5%
1/8 • Number of events 1

Additional Information

Dr. Steven Edgley

University of Utah

Phone: 801-581-4695

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place