a Water Training Program to Improve Balance in Chronic Stroke Patients

This study has been completed.
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00564343
First received: November 25, 2007
Last updated: December 15, 2008
Last verified: November 2007
  Purpose

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.


Condition Intervention
Chronic Stroke Patients
Other: water based training program to improve balance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: a Water Training Program to Improve Balance in Chronic Stroke Patients: Cross- Sectional Pre-Post Study Design

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Secondary Outcome Measures:
  • Berg Balance Scale [ Time Frame: fall will be monitored a year after the completion of the study. ] [ Designated as safety issue: Yes ]
  • Late life Function and Disability Instrument [ Time Frame: fall will be monitored a year after the completion of the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Step execution test under single and dual task [ Time Frame: fall will be monitored a year after the completion of the study ] [ Designated as safety issue: No ]
  • Stability tests [ Time Frame: fall will be monitored a year after the completion of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2007
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564343

Locations
Israel
SorokaUMC
Beer-Sheva, Israel
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Dagan Shvartz, M.D. Ben-gurion University of the Negev, Beer-Sheva, Israel
  More Information

No publications provided

Responsible Party: itshak Melzer, Ben-gurion Univesity
ClinicalTrials.gov Identifier: NCT00564343     History of Changes
Other Study ID Numbers: sor425606ctil, ISRCTN4256
Study First Received: November 25, 2007
Last Updated: December 15, 2008
Health Authority: Israel: Ethics Commission

Keywords provided by Soroka University Medical Center:
Balance
Water based training
Physical functioning
stepping behavior

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 22, 2014