Trial Outcomes & Findings for Talocrural Joint Manipulation in Stroke (NCT NCT06523010)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

64 participants

Primary outcome timeframe

Change from baseline overall stability immediately after intervention

Results posted on

2025-07-23

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Placebo Talocrural Joint Manipulation Group Patients in this group will first receive a placebo talocrural joint manipulation, followed by the actual talocrural joint manipulation after a washout period of at least 48 hours.	Talocrural Joint Manipulation Group Patients in this group will first receive the actual talocrural joint manipulation, followed by the placebo talocrural joint manipulation after a washout period of at least 48 hours.
Overall Study STARTED	32	32
Overall Study COMPLETED	32	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=64 Participants All study participants were involved in the study.
Age, Categorical <=18 years	0 Participants n=64 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=64 Participants
Age, Categorical >=65 years	20 Participants n=64 Participants
Age, Continuous	59.21 years STANDARD_DEVIATION 8.07 • n=64 Participants
Sex: Female, Male Female	24 Participants n=64 Participants
Sex: Female, Male Male	40 Participants n=64 Participants
Region of Enrollment Turkey	32 participants n=64 Participants
Body Mass Index	28.36 kg/m2 STANDARD_DEVIATION 2.99 • n=64 Participants
Height	166.84 centimeter STANDARD_DEVIATION 9.29 • n=64 Participants
Weight	78.93 kilogram STANDARD_DEVIATION 6.74 • n=64 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo Only n=64 Participants Only the pre- and post-intervention values of the patients in this group who received placebo manipulation were taken into account.	Talocrural Manipulation Only n=64 Participants Only the pre- and post-intervention values of the patients in this group who received real manipulation were taken into account.
Overall Stability Index Measurement	17.5 units on a scale Interval 8.0 to 28.0	9 units on a scale Interval 2.0 to 22.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo Only n=64 Participants Only the pre- and post-intervention values of the patients in this group who received placebo manipulation were taken into account.	Talocrural Manipulation Only n=64 Participants Only the pre- and post-intervention values of the patients in this group who received real manipulation were taken into account.
Mediolateral Stability Index Measurement	6.96 units on a scale Standard Deviation 2.59	4.87 units on a scale Standard Deviation 2.76

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo Only n=64 Participants Only the pre- and post-intervention values of the patients in this group who received placebo manipulation were taken into account.	Talocrural Manipulation Only n=64 Participants Only the pre- and post-intervention values of the patients in this group who received real manipulation were taken into account.
Anteroposterior Stability Index Measurement	10 units on a scale Interval 4.0 to 14.0	5.5 units on a scale Interval 1.0 to 12.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Placebo Only n=64 Participants Only the pre- and post-intervention values of the patients in this group who received placebo manipulation were taken into account.	Talocrural Manipulation Only n=64 Participants Only the pre- and post-intervention values of the patients in this group who received real manipulation were taken into account.
Ankle Dorsiflexion Range of Motion Measurement With Knee in Extended and Flexed Positions Knee flexed dorsi flexion	13 average of ankle dorsi flexion degree Interval 8.0 to 35.0	22.5 average of ankle dorsi flexion degree Interval 11.0 to 39.0
Ankle Dorsiflexion Range of Motion Measurement With Knee in Extended and Flexed Positions Knee extended dorsi flexion	10 average of ankle dorsi flexion degree Interval 7.0 to 27.0	18.5 average of ankle dorsi flexion degree Interval 7.0 to 36.0

Adverse Events

All Participants in the Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Asst. Prof. Ömer Dursun

Bitlis Eren University

Phone: 5426088687

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place