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Chronic Stroke PatientsNCT00564343

a Water Training Program to Improve Balance in Chronic Stroke Patients

An observational study of Chronic Stroke Patients, run by Soroka University Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 80 years
Conditions the study is for
Chronic Stroke Patients
What is being tested?
water based training program to improve balance
How many people
20 participants
Where
1 siteIsrael
Study dates
Nov 2007to Jun 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • No healthy volunteers
  • Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • SorokaUMC

    Beersheba

Other trials in Israel

About this study

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

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.

Being tested
water based training program to improve balance
Keywords
Balance, Water based training, Physical functioning, stepping behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • water based training program to improve balanceOther

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

Study groups in NCT00564343
Study groupRoleWhat they receive
ChSt, water training, ObservationSubjects 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.
Receives: Other: water based training program to improve balance

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionMay 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00564343
Sponsor's protocol ID
sor425606ctil
Other IDs
ISRCTN4256
Status last verified
Nov 2007
First submitted
25 Nov 2007
Last updated
16 Dec 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Stroke Patients, run by Soroka University Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2008.

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