Stroke
Conditions
Keywords
postural balance
Brief summary
The primary aim of the study is to investigate the effect of talocrural joint manipulation on the static balance of patients with stroke. The secondary aim of this study is to investigate the effect of talocrural joint manipulation on the dorsiflexion range of motion of patients with stroke.
Detailed description
The study, utilizing a randomized crossover design, is planned to be conducted on a minimum of 26 patients with stroke who meet the inclusion and exclusion criteria. Patients included in the study will be randomly assigned to receive both placebo talocrural joint manipulation and talocrural joint manipulation treatments.
Interventions
This technique, aiming to increase ankle dorsiflexion and mechanoreceptor activation, is based on the application of high velocity low amplitude traction to the joint.
This intervention is a classic method used to evaluate the effect of talocrural joint manipulation.
Sponsors
Bitlis Eren University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The evaluator and the researcher administering the intervention will be different. The interventions will be administered to participants randomly.
Intervention model description
The patients enrolled in the study will receive placebo talocrural joint traction and talocrural joint traction in a randomized sequence. The order of the interventions will be determined by flipping a coin.
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Two months or longer elapsed since the stroke, * 2\. A Mini-Mental State Examination score of 24 or higher, * 3\. The ability to stand independently for 20 seconds or more, * 4\. The ability to walk independently for 10 meters with the use of walking aids or orthoses if necessary, * 5\. Being between 45 and 75 years of age, * 6\. Having a Brunnstrom stage of 4 or above
Exclusion criteria
* 1\. The presence of severe osteoarthritis in the lower extremity, * 2\. The presence of cancer or diabetic neuropathy, * 3\. The presence of vestibular disorder, * 4\. The presence of lower extremity ulceration or amputation, * 5\. History of vertigo, * 6\. Alcohol consumption within the last 24 hours, * 7\. Hemodynamic instability, * 8\. Diagnosis of posterior circulation stroke involving the basilar artery and cerebellum, * 9\. The presence of other neurological disorders (such as multiple sclerosis, Parkinson's disease), * 10\. Having experienced an acute lower extremity injury in the last six weeks, * 11\. History of lower extremity surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Stability Index Measurement | Change from baseline overall stability immediately after intervention | Overall stability index, evaluated using the Biodex Balance System. Overall stability index scores were derived from calculations of deviations from the center of gravity in the anteroposterior and mediolateral axes by the device. A lower score indicates smaller deviation and better postural stability. The assessment was conducted on a stable platform with three 20-second repetitions interspersed with 10-second rest periods. Participants remained standing during the rest periods, and the device automatically computed the average of the three repetitions. As the general stability index value increases, overall stability decreases. No definable minimum or maximum theoretical value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mediolateral Stability Index Measurement | Change from baseline mediolateral stability immediately after intervention | Mediolateral stability index, evaluated using the Biodex Balance System. Mediolateral stability index scores were derived from calculations of deviations from the center of gravity in the mediolateral axis by the device. As the mediolateral index value increases, mediolateral stability decreases. No definable minimum or maximum theoretical value. |
| Anteroposterior Stability Index Measurement | Change from baseline anteroposterior stability immediately after intervention | Anteroposterior stability index, evaluated using the Biodex Balance System. Anteroposterior stability index scores were derived from calculations of deviations from the center of gravity in the anteroposterior axis by the device. As the overall anteroposterior stability value increases, anteroposterior stability decreases. No definable minimum or maximum theoretical value. |
| Ankle Dorsiflexion Range of Motion Measurement With Knee in Extended and Flexed Positions | Change from baseline ankle dorsiflexion range of motion immediately after intervention | The patient was asked to stand facing the wall and place their hands on the wall at shoulder width apart, with the affected foot positioned behind and the knee in full extension. Then, without lifting the back foot or compromising knee extension, the patient was instructed to reach forward as far as possible. Subsequently, the calcaneal tubercle was placed one centimeter above the floor, and the measurement was taken with a water level gauge attached to the phone. The same measurement was repeated with the knee in flexion (20 degrees or more). |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
The study was conducted in compliance with the principles outlined in the 1964 Declaration of Helsinki, and it took place at İzzet Baysal Physical Therapy and Rehabilitation Training and Research Hospital between August 2024, and December 2024.
Pre-assignment details
Before group allocation, one individual was excluded from the study due to being over 75 years of age, 29 individuals due to cognitive dysfunction, 2 individuals due to lower extremity amputation, and 90 individuals because their Brunnstrom recovery stage was below stage four.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All study participants were involved in the study. | 64 |
| Total | 64 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 20 Participants | — |
| Age, Categorical Between 18 and 65 years | 44 Participants | — |
| Age, Continuous | 59.21 years STANDARD_DEVIATION 8.07 | — |
| Body Mass Index | 28.36 kg/m2 STANDARD_DEVIATION 2.99 | — |
| Height | 166.84 centimeter STANDARD_DEVIATION 9.29 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Turkey | 32 participants | — |
| Sex: Female, Male Female | 24 Participants | — |
| Sex: Female, Male Male | 40 Participants | — |
| Weight | 78.93 kilogram STANDARD_DEVIATION 6.74 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 64 |
| other Total, other adverse events | 0 / 64 |
| serious Total, serious adverse events | 0 / 64 |
Outcome results
Primary
Overall Stability Index Measurement
Overall stability index, evaluated using the Biodex Balance System. Overall stability index scores were derived from calculations of deviations from the center of gravity in the anteroposterior and mediolateral axes by the device. A lower score indicates smaller deviation and better postural stability. The assessment was conducted on a stable platform with three 20-second repetitions interspersed with 10-second rest periods. Participants remained standing during the rest periods, and the device automatically computed the average of the three repetitions. As the general stability index value increases, overall stability decreases. No definable minimum or maximum theoretical value.
Time frame: Change from baseline overall stability immediately after intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Only | Overall Stability Index Measurement | 17.5 units on a scale |
| Talocrural Manipulation Only | Overall Stability Index Measurement | 9 units on a scale |
Secondary
Ankle Dorsiflexion Range of Motion Measurement With Knee in Extended and Flexed Positions
The patient was asked to stand facing the wall and place their hands on the wall at shoulder width apart, with the affected foot positioned behind and the knee in full extension. Then, without lifting the back foot or compromising knee extension, the patient was instructed to reach forward as far as possible. Subsequently, the calcaneal tubercle was placed one centimeter above the floor, and the measurement was taken with a water level gauge attached to the phone. The same measurement was repeated with the knee in flexion (20 degrees or more).
Time frame: Change from baseline ankle dorsiflexion range of motion immediately after intervention
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo Only | Ankle Dorsiflexion Range of Motion Measurement With Knee in Extended and Flexed Positions | Knee flexed dorsi flexion | 13 average of ankle dorsi flexion degree |
| Placebo Only | Ankle Dorsiflexion Range of Motion Measurement With Knee in Extended and Flexed Positions | Knee extended dorsi flexion | 10 average of ankle dorsi flexion degree |
| Talocrural Manipulation Only | Ankle Dorsiflexion Range of Motion Measurement With Knee in Extended and Flexed Positions | Knee flexed dorsi flexion | 22.5 average of ankle dorsi flexion degree |
| Talocrural Manipulation Only | Ankle Dorsiflexion Range of Motion Measurement With Knee in Extended and Flexed Positions | Knee extended dorsi flexion | 18.5 average of ankle dorsi flexion degree |
Secondary
Anteroposterior Stability Index Measurement
Anteroposterior stability index, evaluated using the Biodex Balance System. Anteroposterior stability index scores were derived from calculations of deviations from the center of gravity in the anteroposterior axis by the device. As the overall anteroposterior stability value increases, anteroposterior stability decreases. No definable minimum or maximum theoretical value.
Time frame: Change from baseline anteroposterior stability immediately after intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Only | Anteroposterior Stability Index Measurement | 10 units on a scale |
| Talocrural Manipulation Only | Anteroposterior Stability Index Measurement | 5.5 units on a scale |
Secondary
Mediolateral Stability Index Measurement
Mediolateral stability index, evaluated using the Biodex Balance System. Mediolateral stability index scores were derived from calculations of deviations from the center of gravity in the mediolateral axis by the device. As the mediolateral index value increases, mediolateral stability decreases. No definable minimum or maximum theoretical value.
Time frame: Change from baseline mediolateral stability immediately after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Only | Mediolateral Stability Index Measurement | 6.96 units on a scale | Standard Deviation 2.59 |
| Talocrural Manipulation Only | Mediolateral Stability Index Measurement | 4.87 units on a scale | Standard Deviation 2.76 |