Patients Who Are in Need of Short or Long Term Rehabilitation Due to Neurological Event (Mainly Stroke) or Post Orthopedic SurgeryNCT01074788
Mind Body Therapy During Geriatric Rehabilitation
A study testing mind body therapy in people with Patients Who Are in Need of Short or Long Term Rehabilitation Due to Neurological Event (Mainly Stroke) or Post Orthopedic Surgery, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The main goal of geriatric rehabilitation following an acute illness is rapid restoration of normal activity. The key elements are pain control, restoration of bowel functions, good sleep quality, appetite and general well-being, as well as return to pre illness physical capabilities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Who Are in Need of Short or Long Term Rehabilitation Due to Neurological Event (Mainly Stroke) or Post Orthopedic Surgery
- What is being tested?
- mind body therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2009to Nov 2010
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients,age 18 and above.
- Getting standard rehabilitation therapy
- Can fill an informed consent.
Who cannot join
- Medically unstable patients (uncontrolled heart failure,rapid AF, severe infection, constant need of oxygen therapy).
- Demented patients who are unable to fill an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The main goal of geriatric rehabilitation following an acute illness is rapid restoration of normal activity. The key elements are pain control, restoration of bowel functions, good sleep quality, appetite and general well-being, as well as return to pre illness physical capabilities. Emphasis has recently been placed on finding innovative multi-disciplinary methods that can improve the care of elderly people who had suffered an acute illness. The aim of this prospective study is to assess the effect of mind-body therapy(including guided imagery, relaxation techniques, mediation and touch therapy) as as an adjunct to medical and physical rehabilitation in geriatric patients.
- Being tested
- mind body therapy
- Keywords
- rehabilitation, mind body therapy, integrative medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mind body therapyBehavioural
mind-body therapy includes guided imagery, relaxation techniques, mediation and touch therapy.
| Study group | Role | What they receive |
|---|---|---|
| mind body intervention group | Experimental | Not described Receives: Behavioral: mind body therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect on quality of life
Measured: 1 year
Secondary outcomes (1)
effect of treatment on rehabilitation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Who Are in Need of Short or Long Term Rehabilitation Due to Neurological Event (Mainly Stroke) or Post Orthopedic SurgeryStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074788
- Sponsor's protocol ID
- tasmc-09-yl-0488
- Other IDs
- tasmc0488-09
- Status last verified
- Feb 2010
- First submitted
- 23 Feb 2010
- Last updated
- 24 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind Body Therapy During Geriatric Rehabilitation
- ClinicalTrials.gov ID
- NCT01074788
- Acronym / sponsor ID
- tasmc-09-yl-0488
- Keywords
- rehabilitation, mind body therapy, integrative medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (estimated)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of geriatric rehabilitation following an acute illness is rapid restoration of normal activity. The key elements are pain control, restoration of bowel functions, good sleep quality, appetite and general well-being, as well as return to pre illness physical capabilities. Emphasis has recently been placed on finding innovative multi-disciplinary methods that can improve the care of elderly people who had suffered an acute illness. The aim of this prospective study is to assess the effect of mind-body therapy(including guided imagery, relaxation techniques, mediation and touch therapy) as as an adjunct to medical and physical rehabilitation in geriatric patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mind body intervention group | Experimental | Behavioral: mind body therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inpatients,age 18 and above.
- Getting standard rehabilitation therapy
- Can fill an informed consent.
Key exclusion criteria (2 listed)
- Medically unstable patients (uncontrolled heart failure,rapid AF, severe infection, constant need of oxygen therapy).
- Demented patients who are unable to fill an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mind body therapymind-body therapy includes guided imagery, relaxation techniques, mediation and touch therapy. | Behavioural | mind body intervention group |
Primary outcome
effect on quality of life
Time frame: 1 year
1 secondary outcome
effect of treatment on rehabilitation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mind body therapy in people with Patients Who Are in Need of Short or Long Term Rehabilitation Due to Neurological Event (Mainly Stroke) or Post Orthopedic Surgery, run by Tel-Aviv Sourasky 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Feb 2010. 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
effect on quality of life (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 24 Feb 2010.