Clinical trial NCT05833295: Electrophysiological and Clinical Effects of Walking Downhill in Stroke Patients
Official title: Electrophysiological and Clinical Effects of Walking Downhill in Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: investigation of the effects of walking for 20 minutes on the acute H/M ratio on flat ground, downhill slopes at -7.5 degrees and -15 degrees in patients who have had a stroke, have spasticity and are ambulatory.

At the same time, the aim of the study is to obtain the clinical effectiveness of this walking pattern and control of the H/M ratio by checking the H/M ratio again after 5 sessions and 20 minutes of walking for the patients participating in the study.

Detailed description: Participants will wear a seat belt connected to an overhead support and will walk on a treadmill with a dual-band instrument at a sampling frequency of 2000 Hz. The seat belt will only serve as a safety mechanism in case of a fall and will not support any body weight while walking. Each participant will walk for 20 minutes under one of 3 slope conditions; treadmill walking on 0° flat ground, , downhill walking with treadmill on -7.5° slope and downhill walking with treadmill on -15° slope.

First, by asking the participants to walk at their comfortable speed for straight walking on the treadmill with tools, the walking speed will be determined and carried out at the specified speeds. All self-selected walking speeds will be determined in two 30-second trials. During the 20-minute walk for each condition, if the participant needs to slow down, the speed of the treadmill will be reduced to adapt to this, and the average walking speed during the 20-minute walking session will be reported. Pulse and blood pressure will be monitored before, during and after the walk.

All participants will be evaluated with modified asworth scale, modified tardeu scale, 2 minute walking test, modified rankin scale, timed get up and walk test, fatigue impact scale, stroke impact scale, berg balance scale, fugl meyer assessment scale before treatment.

Patients will be randomized into 3 groups. Then, the H / M ratio will be looked at in all 3 groups. After the first walking session, the H / M ratio will be repeated. after completing the 5-session walking program, clinical and electrophysiological tests will be repeated.

Eligibility criteria: Inclusion Criteria:

patients diagnosed with stroke between the ages of 18 and 65 Dec

Exclusion Criteria:

* Other neurological disorders,

  * Expressive or receptive aphasias,
  * Severe heart disease,
  * A history of poorly controlled diabetes,
  * Active cancer,
* Those who have been injected with botilinum toxin in the last 3 months,

  * Orthopedic conditions affecting the legs, a history of hip or knee replacement,
  * Serious simultaneous medical problems, such as peripheral nerve damage
* Inability to comprehend verbal instructions

Primary outcomes:
measure: the change in the H/M ratio after a 20-minute walk.
timeFrame: Day 0: Before the walk
measure: the change in the H/M ratio after a 20-minute walk.
timeFrame: Day 1: First day of 20-minute walk
measure: the change in the H/M ratio after a 20-minute walk.
timeFrame: Day 5: The fifth day of the 20-minute walk
Secondary outcomes:
measure: Modified Asworth Scale
timeFrame: Day 0: Before the walk
measure: Modified Asworth Scale
timeFrame: Day 5: The fifth day of the 20-minute walk
measure: Modified Tardeu Scale
timeFrame: Day 0: Before the walk
measure: Modified Tardeu Scale
timeFrame: Day 5: The fifth day of the 20-minute walk
measure: Walking test
timeFrame: Day 0: Before the walk
measure: Walking test
timeFrame: Day 5: The fifth day of the 20-minute walk
measure: Walking capacity
timeFrame: Day 0: Before the walk
measure: Walking capacity
timeFrame: Day 5: The fifth day of the 20-minute walk
measure: The Fatigue Effect Scale
timeFrame: Day 0: Before the walk
measure: Fatigue
timeFrame: Day 5: The fifth day of the 20-minute walk
measure: Stroke impact scale
timeFrame: Day 0: Before the walk
measure: Stroke impact scale
timeFrame: Day 5: The fifth day of the 20-minute walk
measure: Berg Equilibrium Scale
timeFrame: Day 0: Before the walk
measure: Berg Equilibrium Scale
timeFrame: Day 5: The fifth day of the 20-minute walk
measure: Fugl-Meyer Assessment Scale
timeFrame: Day 0: Before the walk
measure: Fugl-Meyer Assessment Scale
timeFrame: Day 5: The fifth day of the 20-minute walk
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Mamara Üniversitesi Tıp Fakültesi
Study officials:
References: