Trial Outcomes & Findings for Body Awareness Therapy for People With Stroke (NCT NCT01613339)
NCT ID: NCT01613339
Last Updated: 2018-06-28
Results Overview
Test of functional balance. Includes 14 items all graded 0-4 where 0 indicate larger impairment. Total score is used here, maximum 56 and minimum 0. The Berg balance scale was developed for older patients but is a much used meausure of dynamic and static functional balance.
COMPLETED
NA
46 participants
Change from baseline in Bergs balance scale at 9 weeks
2018-06-28
Participant Flow
Data collection was performed in the following order due to practical reason at four primary health care centres in Örebro county council; Kumla Primary health care center, October 2011- January 2012, Karla Primary health care centre, March 2012-June 2012, Nora and Brickegården Primary health care centre September 2012 to December 2012.
Participant milestones
| Measure |
Body Awareness Therapy
Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
|
Control
No specific treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
22
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Body Awareness Therapy for People With Stroke
Baseline characteristics by cohort
| Measure |
Body Awareness Therapy
n=24 Participants
Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
|
Control
n=22 Participants
No specific treatment.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 11 • n=99 Participants
|
66 years
STANDARD_DEVIATION 9 • n=107 Participants
|
64 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Region of Enrollment
Sweden
|
24 participants
n=99 Participants
|
22 participants
n=107 Participants
|
46 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from baseline in Bergs balance scale at 9 weeksTest of functional balance. Includes 14 items all graded 0-4 where 0 indicate larger impairment. Total score is used here, maximum 56 and minimum 0. The Berg balance scale was developed for older patients but is a much used meausure of dynamic and static functional balance.
Outcome measures
| Measure |
Body Awareness Therapy
n=21 Participants
Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
|
Control
n=21 Participants
No specific treatment.
|
|---|---|---|
|
Bergs Balance Scale
|
52.3 units on a scale
Standard Deviation 4.8
|
47.8 units on a scale
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Change from baseline in Timed Up and Go test at 9 weekstest of functional mobility. Time is taken in seconds. The participants sits on a chair with armrests are then asked to rise, walk 3 meters, turn and walk back and sit down.
Outcome measures
| Measure |
Body Awareness Therapy
n=21 Participants
Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
|
Control
n=21 Participants
No specific treatment.
|
|---|---|---|
|
Timed Up and Go Test
|
13.7 seconds
Standard Deviation 7.3
|
17.6 seconds
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: Change from baseline in Activities-specific Balance confidence scale at 9 weeks16 item questionnaire that investigates balance self-efficacy. Each items is a question; How secure are you that you will not fall when you...sweep the floor? The participant are asked to grade his/hers feeling of secutiry from 0, 10, 20 and so on up to 100. 0 is regarded low balance self-efficacy. The item responses are summed and divided by 16.
Outcome measures
| Measure |
Body Awareness Therapy
n=21 Participants
Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
|
Control
n=22 Participants
No specific treatment.
|
|---|---|---|
|
Activities-specific Balance Confidence Scale
|
68.6 units on a scale
Standard Deviation 20.3
|
59.1 units on a scale
Standard Deviation 22.0
|
Adverse Events
Body Awareness Therapy, Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place