a Water Training Program to Improve Balance in Chronic Stroke Patients

• ClinicalTrials.gov Identifier: NCT00564343
• Recruitment Status: Completed
• First Posted: November 27, 2007
• Last Update Posted: December 16, 2008
• Sponsor: Soroka University Medical Center
• Information provided by: Soroka University Medical Center

Tracking Information

• First Submitted Date: November 25, 2007
• First Posted Date: November 27, 2007
• Last Update Posted Date: December 16, 2008
• Study Start Date: November 2007
• Actual Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: November 26, 2007)

• Berg Balance Scale [ Time Frame: fall will be monitored a year after the completion of the study. ]
• Late life Function and Disability Instrument [ Time Frame: fall will be monitored a year after the completion of the study ]
• Get up and go test - stand up and walk 3 meters turn around and walk back to the chair [ Time Frame: fall will be monitored a year after the completion of the study ]
• Step execution test under single and dual task [ Time Frame: fall will be monitored a year after the completion of the study ]
• Stability tests [ Time Frame: fall will be monitored a year after the completion of the study ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: a Water Training Program to Improve Balance in Chronic Stroke Patients
• Official Title: a Water Training Program to Improve Balance in Chronic Stroke Patients: Cross- Sectional Pre-Post Study Design

Brief Summary

The proposed project is a case control study design. Subject's suffer from stroke willing to participate in the study will be shortly interviewed to assess eligibility according to the inclusion-exclusion criteria. Subjects suffer from chronic hemiplegia that upon questioning was judged to meet the following inclusion criteria: (a) able to stand independently 90 seconds; (b) able to walk 10 meters (with cane if necessary); (c) able to understand verbal instructions. The exclusion criteria will be: (a) Serious visual impairment; (b) Inability to ambulate independently (cane acceptable, walker not). (c) Severely impaired cognitive status (score less then 24 in Mini Mental State Examination). (d) Persons with impaired communication capabilities.

The whole project will be conducted over a period of 3 months. A total of 36 subjects will be assigned to water based exercise program. The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week). The subjects of the exercise group will be recruited from Sha'ar Ha'negev Swimming pool and from patients that get a Physical Therapy treatment Kupat Holim Clalit.

Gait and balance function will be tested in both groups with well established measuring techniques before and after the training period. The measuring techniques 1) Medical background variables. 2) Berg Balance Scale. 3) Late life Function and Disability Instrument. 4) Get up and go test - stand up and walk 3 meters turn around and walk back to the chair. 5) step execution test under single and dual task; 5) stability tests. 6) also fall will be monitored a year after the completion of the study. The water training intervention is performed on different levels where each level reflects different increasing demands on the postural control system. For example, the instructor can increase the difficulty of a certain water-exercise by instructing a participant to use less external support, close the eyes, decrease the support area (stand on one leg or narrow the stance, or on unstable surface). These "tools" allow the instructor to implement step exercises on a group level that are still challenging for each individual even if the skill level in the group varies. The water exercises also include perturbation exercises that trigger specific reflex-like balance responses. On each level the instructor can instantly modify an exercise to be more or less challenging for each participant.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: The subjects of the exercise group will be recruited from Sha'ar Ha'negev Swimming pool and from patients that get a Physical Therapy treatment Kupat Holim Clalit.
• Condition: Chronic Stroke Patients

Intervention

Other: water based training program to improve balance

The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week), 45 minute training session.

Study Groups/Cohorts

ChSt, water training, Observation

Subjects suffer from chronic hemiplegia (a year or more post stroke) that upon questioning was judged to meet the following inclusion criteria: (a) able to stand independently 90 seconds; (b) able to walk 10 meters (with cane if necessary); (c) able to understand verbal instructions. The exclusion criteria will be: (a) Serious visual impairment; (b) Inability to ambulate independently (cane acceptable, walker not). (c) Severely impaired cognitive status (score less then 24 in Mini Mental State Examination). (d) Persons with impaired communication capabilities.

Intervention: Other: water based training program to improve balance

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: November 26, 2007): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2008
• Actual Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Subjects suffer from chronic hemiplegia (a year or more)
2. able to stand independently 90 seconds;
3. able to walk 10 meters (with cane if necessary);
4. able to understand verbal instructions.

Exclusion Criteria:

1. Serious visual impairment;
2. Inability to ambulate independently (cane acceptable, walker not).
3. Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
4. Persons with impaired communication capabilities.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years to 80 Years (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00564343
• Other Study ID Numbers: sor425606ctil; ISRCTN4256
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: itshak Melzer, Ben-gurion Univesity
• Original Responsible Party: Not Provided
• Current Study Sponsor: Soroka University Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dagan Shvartz, M.D.; Ben-gurion University of the Negev, Beer-Sheva, Israel

• PRS Account: Soroka University Medical Center
• Verification Date: November 2007