a Water Training Program to Improve Balance in Chronic Stroke Patients

NCT00564343 | Completed DMC

• 2 other identifiers: sor425606ctilISRCTN4256
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke Patients

Keywords

Balance; Water based training; Physical functioning; stepping behavior

Outcome Measures

Secondary Outcomes (5)

• Berg Balance Scale

  fall will be monitored a year after the completion of the study.

• Late life Function and Disability Instrument

  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

  fall will be monitored a year after the completion of the study

• Step execution test under single and dual task

  fall will be monitored a year after the completion of the study

• Stability tests

  fall will be monitored a year after the completion of the study

Study Arms (1)

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

Interventions

water based training program to improve balance OTHER

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

ChSt, water training, Observation

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

SorokaUMC

Beersheba, Israel

Location

Study Officials

• Dagan Shvartz, M.D.

  Ben-gurion University of the Negev, Beer-Sheva, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 25, 2007
• First Posted: November 27, 2007
• Study Start: November 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 16, 2008

Record last verified: 2007-11

Locations

IL (1)